Medicine, Faculty of
Obstetrics and Gynaecology, Department of
DSpace
UBCV
Lawrence, Claire
Master of Science - MSc
University of British Columbia
Postpartum depression (PPD) and anxiety (PPA) affect about one-quarter (23%) of women in Canada. Despite this high prevalence, barriers exist making treatment inaccessible for many. Web-enabled resources are a promising solution, increasing access to mental health resources for women in the postpartum period. However, a patient-centered approach is not routinely taken in the development of web resources, leaving postpartum women out of critical decision-making processes. This study aimed to evaluate the effectiveness, usability, and user satisfaction of PostpartumCare.ca, a web-enabled psychoeducational resource for postpartum mental health, created in partnership with women in British Columbia (BC) affected by postpartum mental illness. Women experiencing PPD and/or PPA from BC who gave birth in the past 12 months were enrolled. Fifty-two were randomized to the intervention group (mean age 31.60 ± 5.12 years), receiving access to PostpartumCare.ca for four weeks, and 51 to a waitlist control group (mean age 34.25 ± 4.84 years). Participants completed measures evaluating PPD (Edinburgh Postnatal Depression Scale [EPDS]) and PPA (Perinatal Anxiety Screening Scale [PASS]) symptoms at baseline, after four weeks, and after a two-week follow-up. Intervention participants also completed measures of website usability and satisfaction after four weeks, and their website metrics were collected. PPD and PPA symptoms were significantly reduced for the intervention group following the use of PostpartumCare.ca, with improvements maintained after a two-week follow-up, corresponding with small-to-medium effect sizes (PPD: partial η² = .03; PPA: partial η² = .04). Intervention participants were also more likely than waitlist controls to recover from clinical levels of PPD symptoms. Overall satisfaction with PostpartumCare.ca was above average, with most reporting perceived changes in depressive and/or anxiety symptoms and endorsing the website’s technical adequacy, content quality, and appearance. Findings suggest that a web-enabled psychoeducational resource, created in collaboration with patient partners, can be effective in reducing symptoms of PPD and PPA, supporting its use as a low-barrier first-line option for women in BC experiencing postpartum mental health concerns.
EVALUATING THE EFFECTIVENESS OF A WEB-ENABLED PSYCHOEDUCATIONAL INTERVENTION FOR POSTPARTUM MENTAL HEALTH FOR WOMEN IN BRITISH COLUMBIA by Claire Lawrence BHSc (Honors), McMaster University, 2021 A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE in THE FACULTY OF GRADUATE AND POSTDOCTORAL STUDIES (Women+ and Children’s Health Sciences) THE UNIVERSITY OF BRITISH COLUMBIA (Vancouver) August 2023 © Claire Lawrence, 2023 ii The following individuals certify that they have read, and recommend to the Faculty of Graduate and Postdoctoral Studies for acceptance, a thesis entitled: Evaluating the Effectiveness of a Web-Enabled Psychoeducational Intervention for Postpartum Mental Health for Women in British Columbia submitted by Claire Lawrence in partial fulfillment of the requirements for the degree of Master of Science in Women+ and Children’s Health Sciences Examining Committee: Lori Brotto, Professor, Department of Obstetrics & Gynaecology, University of British Columbia Supervisor Genevieve Breau, Lecturer, School of Human Sciences, University of Greenwich Co-supervisor Gillian Hanley, Associate Professor, Department of Obstetrics & Gynaecology, University of British Columbia Supervisory Committee Member Nichole Fairbrother, Clinical Associate Professor, Department of Family Practice, University of British Columbia Supervisory Committee Member Patricia Janssen, Professor, School of Population and Public Health, University of British Columbia Additional Examiner iii Abstract Postpartum depression (PPD) and anxiety (PPA) affect about one-quarter (23%) of women in Canada. Despite this high prevalence, barriers exist making treatment inaccessible for many. Web-enabled resources are a promising solution, increasing access to mental health resources for women in the postpartum period. However, a patient-centered approach is not routinely taken in the development of web resources, leaving postpartum women out of critical decision-making processes. This study aimed to evaluate the effectiveness, usability, and user satisfaction of PostpartumCare.ca, a web-enabled psychoeducational resource for postpartum mental health, created in partnership with women in British Columbia (BC) affected by postpartum mental illness. Women experiencing PPD and/or PPA from BC who gave birth in the past 12 months were enrolled. Fifty-two were randomized to the intervention group (mean age 31.60 ± 5.12 years), receiving access to PostpartumCare.ca for four weeks, and 51 to a waitlist control group (mean age 34.25 ± 4.84 years). Participants completed measures evaluating PPD (Edinburgh Postnatal Depression Scale [EPDS]) and PPA (Perinatal Anxiety Screening Scale [PASS]) symptoms at baseline, after four weeks, and after a two-week follow-up. Intervention participants also completed measures of website usability and satisfaction after four weeks, and their website metrics were collected. PPD and PPA symptoms were significantly reduced for the intervention group following the use of PostpartumCare.ca, with improvements maintained after a two-week follow-up, corresponding with small-to-medium effect sizes (PPD: partial η2 = .03; PPA: partial η2 = .04). Intervention participants were also more likely than waitlist controls to recover from clinical iv levels of PPD symptoms. Overall satisfaction with PostpartumCare.ca was above average, with most reporting perceived changes in depressive and/or anxiety symptoms and endorsing the website’s technical adequacy, content quality, and appearance. Findings suggest that a web-enabled psychoeducational resource, created in collaboration with patient partners, can be effective in reducing symptoms of PPD and PPA, supporting its use as a low-barrier first-line option for women in BC experiencing postpartum mental health concerns. v Lay Summary Postpartum depression and anxiety affect around one-quarter of women in Canada. Despite this, many don’t get the help they need due to barriers preventing access to care. Web-based interventions can provide a solution to this; however, the contribution of postpartum women with lived experience is not commonly considered in the web development process. In response to this, our study aimed to evaluate the effectiveness, usability, and user satisfaction of PostpartumCare.ca, an educational website created in partnership with postpartum women in BC. Women enrolled in our study were randomized to either an intervention or waitlist control group and their depression and anxiety symptoms were measured before and after using the website. Our results found that after using the website for four weeks, symptoms of depression and anxiety improved, and the website was well-received by women. This website may be a useful tool for women in BC in need of accessible support. vi Preface This thesis is an original, unpublished, intellectual product of the author, Claire Lawrence, under the supervision of Dr. Lori Brotto and Dr. Genevieve Breau. Dr. Brotto and Dr. Breau brought to me the opportunity to carry out the third stage of a multiphase study to evaluate the effectiveness of a web-intervention that had previously been designed and feasibility tested by members of Dr. Lori Brotto’s research team at the University of British Columbia. When I first began work on this project, the study protocol and design were previously outlined by Dr. Brotto and Dr. Breau, though I was responsible for editing/finalizing their later versions and applying for research ethics approval. I went on to independently carry out the study protocol for the current randomized trial, including recruitment, screening and enrollment, data collection, and all participant communications. I also led the analysis and interpretation phase of this research, with the guidance of statistician Dr. Bozena Zdaniuk. During the study, I also had assistance from three research assistants. The first, Angelina Hollihn (a UBC psychology undergraduate student), helped with contacting participants by phone to obtain verbal consent for study participation. The second, Lily Yang (a UBC medical student), helped with the analysis of demographic data for the study. The third, Orli Sacks (a UBC psychology undergraduate student), helped with the analysis of website metrics data for the study. All study procedures were approved and carried out in accordance with the guidelines set by the University of British Columbia and BC Children’s and Women’s Hospital Research Ethics Board (REB number: H21-01379). vii Table of Contents Abstract ......................................................................................................................................... iii Lay Summary .................................................................................................................................v Preface ........................................................................................................................................... vi Table of Contents ........................................................................................................................ vii List of Tables ................................................................................................................................ xi List of Figures .............................................................................................................................. xii List of Abbreviations ................................................................................................................. xiii Acknowledgements ......................................................................................................................xv Dedication ................................................................................................................................... xvi Chapter 1: Introduction ................................................................................................................1 1.1 Postpartum Depression and Anxiety ............................................................................... 1 1.1.1 Prevalence and Impact ................................................................................................ 1 1.1.2 Definitions................................................................................................................... 2 1.1.3 Gender Diversity Considerations ................................................................................ 3 1.1.4 Current Treatments ..................................................................................................... 4 1.1.5 Barriers to Accessing Care.......................................................................................... 5 1.2 eHealth ............................................................................................................................ 7 1.2.1 Uses in Mental Healthcare .......................................................................................... 7 1.2.2 Examples of Uses in Postpartum Mental Health ........................................................ 8 1.2.3 Patient Partnership in Current Postpartum eHealth Interventions .............................. 9 1.3 Previous Study Phases .................................................................................................. 11 viii 1.3.1 Focus Group Study Findings .................................................................................... 11 1.3.2 Website Development ............................................................................................... 13 1.3.3 Feasibility Study Findings ........................................................................................ 14 1.4 Objectives and Hypotheses ........................................................................................... 15 Chapter 2: Methods .....................................................................................................................17 2.1 Participants .................................................................................................................... 17 2.1.1 Inclusion Criteria ...................................................................................................... 17 2.1.2 Recruitment ............................................................................................................... 18 2.1.3 Power and Sample Size ............................................................................................. 19 2.2 Procedures ..................................................................................................................... 19 2.2.1 Screening and Enrollment ......................................................................................... 19 2.2.2 Randomization .......................................................................................................... 20 2.2.3 Intervention and Waitlist Control Conditions ........................................................... 20 2.2.4 Data Collection Timepoints ...................................................................................... 25 2.2.5 Ethical Considerations .............................................................................................. 25 2.3 Measures ....................................................................................................................... 26 2.3.1 Demographic Characteristics .................................................................................... 26 2.3.2 Primary Outcome: PPD Symptoms .......................................................................... 27 2.3.3 Primary Outcome: PPA Symptoms .......................................................................... 28 2.3.4 Secondary Outcome: Website Usability and Satisfaction ........................................ 28 2.3.5 Secondary Outcome: Website Metrics...................................................................... 31 2.4 Data Analysis Plan ........................................................................................................ 31 2.4.1 Statistical Analyses ................................................................................................... 31 ix 2.4.2 Missing Data ............................................................................................................. 32 2.4.3 Calculating Clinical Significance ............................................................................. 33 Chapter 3: Results........................................................................................................................34 3.1 Participants .................................................................................................................... 34 3.1.1 Retention ................................................................................................................... 34 3.1.2 Characteristics ........................................................................................................... 36 3.1.3 Baseline Demographic Comparisons ........................................................................ 36 3.1.4 Baseline PPD and PPA Symptom Comparisons ....................................................... 37 3.2 Primary Outcome Analyses .......................................................................................... 41 3.2.1 Effects of the Intervention on PPD and PPA Symptoms .......................................... 41 3.2.2 Clinical Significance for PPD ................................................................................... 44 3.2.3 Clinical Significance for PPA ................................................................................... 45 3.3 Secondary Outcome Analyses ...................................................................................... 46 Chapter 4: Discussion ..................................................................................................................48 4.1 Principal Findings ......................................................................................................... 48 4.2 Web-Enabled Psychoeducational Resource can Improve Symptoms of PPD and PPA49 4.3 User Perceptions of PostpartumCare.ca ........................................................................ 51 4.4 Taking a Patient-Centered Approach ............................................................................ 52 4.5 Clinical Implications of Findings.................................................................................. 53 Chapter 5: Conclusion .................................................................................................................55 5.1 Limitations .................................................................................................................... 55 5.2 Strengths ....................................................................................................................... 57 5.3 Significance and Future Directions ............................................................................... 58 x References .....................................................................................................................................59 Appendices ....................................................................................................................................74 Appendix A - Recruitment ........................................................................................................ 74 A.1 Recruitment Social Media Post Blurb....................................................................... 74 A.2 Recruitment Social Media Post ................................................................................. 75 A.3 Recruitment Poster .................................................................................................... 76 A.4 REACH BC Advertisement ...................................................................................... 77 Appendix B - Questionnaires .................................................................................................... 80 B.1 Eligibility and Demographic Questionnaire ............................................................. 80 B.2 Depression and Anxiety Questionnaire .................................................................... 94 B.3 Website Usability and Satisfaction Questionnaire .................................................. 102 Appendix C - Analysis ............................................................................................................ 115 C.1 Meeting ANOVA Assumptions .............................................................................. 115 C.2 Demographic Comparisons Tables ......................................................................... 116 C.3 Pairwise Comparisons Table................................................................................... 120 C.4 System Usability and Satisfaction Measures Table ................................................ 121 C.5 Website Metrics Table ............................................................................................ 122 xi List of Tables Table 1 Description of Website Content by Section......................................................................23 Table 2 Demographic Characteristics of Intervention and Waitlist Control Group Participants at Baseline (T1)..............................................................................................................................38 Table 3 Postpartum Depression and Anxiety Scores of Intervention and Waitlist Control Participants at Baseline (T1) Reported as Mean ± SD..................................................................41 Table 4 Primary Outcomes of Postpartum Depression and Anxiety Scores by Time of Assessment and Group Reported as Mean ± SD...............................................................................................43 Table 5 Comparison of PPD Recovery and Group from T1 to T3 Reported as N (%).................45 Table 6 Comparison of Clinically Significant PPA Improvement and Group from T1 to T3 Reported as N (%)..........................................................................................................................45 Table A1 Independent T-Test Results Comparing Intervention to Waitlist Control Participants on Continuous Demographic Variables at Baseline (T1)............................................................116 Table A2 Chi-Square Test Results Comparing Intervention to Waitlist Control Participants on Categorical Demographic Variables at Baseline (T1)................................................................117 Table A3 Pairwise Comparisons for the Interaction Effect of Time of Assessment and Group on Postpartum Depression and Anxiety Scores................................................................................120 Table A4 Descriptive Statistics of Website Usability and Satisfaction Outcome Variables by Intervention Participants at T2....................................................................................................121 Table A5 Website Metrics of Intervention Participants by Website Section..............................122 xii List of Figures Figure 1 Desktop Interface of PostpartumCare.ca.......................................................................24 Figure 2 Smartphone Interface of PostpartumCare.ca.................................................................24 Figure 3 CONSORT Diagram.......................................................................................................35 Figure 4 Postpartum Depression (EPDS) Scores by Time of Assessment and Group Reported as Mean ± SE......................................................................................................................................43 Figure 5 Postpartum Anxiety (PASS) Scores by Time of Assessment and Group Reported as Mean ± SE......................................................................................................................................44 xiii List of Abbreviations ANCOVA Analysis of Covariance ANOVA Analysis of Variance BC British Columbia CAD Canadian Dollar CBT Cognitive Behavioural Therapy DSM-5 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition EPDS Edinburgh Postnatal Depression Scale FHA Fraser Health Authority GAD-7 Generalized Anxiety Disorder 7-Item Questionnaire GED General Educational Development IHA Interior Health Authority ITT Intention-To-Treat KT Knowledge Translation MCAR Missing Completely at Random MNAR Missing Not at Random NDRI Norepinephrine and Dopamine Reuptake Inhibitor NHA Northern Health Authority NIH National Institutes of Health PASS Perinatal Anxiety Screening Scale PEMAT Patient Education Materials Assessment Tool PGIC Patient Global Impression of Change xiv PPA Postpartum Anxiety PPD Postpartum Depression RCI Reliable Change Index SSRI Selective Serotonin Reuptake Inhibitor SUS System Usability Scale UPWQI User-Perceived Web Quality Instrument VIHA Vancouver Island Health Authority xv Acknowledgements First, I would like to thank my supervisors Dr. Lori Brotto and Dr. Genevieve Breau for providing me the opportunity to work on such an impactful and interesting project and for their continued support throughout my graduate studies. Working under their supervision has given me the opportunity to learn from and collaborate with teams from multiple institutions, which has been an invaluable experience. Additionally, I would like to extend my gratitude to my supervisory/examining committee members; Dr. Gillian Hanley, Dr. Nichole Fairbrother, and Dr. Patricia Janssen for their continued flexibility and guidance, and to Nick Rizzo from the UBC Faculty of Graduate and Postdoctoral Studies for providing guidance on thesis formatting. This research would not have been possible without generous donations from the Diamond Foundation and the Gillespie Family Foundation, coordinated by the BC Women’s Health Foundation. My salary was also supported in part by the Canadian Graduate Scholarship – Master’s Award through the Canadian Institutes of Health Research. I would also like to thank all of the members of the UBC Sexual Health Research Lab and the Women’s Health Research Institute for their incredible support and friendship. In particular, my gratitude goes out to the statistical expertise of Dr. Bozena Zdaniuk who has helped shape my knowledge of statistical analysis, and to research assistants Angelina Hollihn, Lily Yang, and Orli Sacks who supported tasks throughout this project. My final and most special thank you is reserved for my parents, Burke and Lori, two artists who devote themselves tirelessly to understanding and championing their eldest daughter's inner scientist. xvi Dedication This work is dedicated to those struggling with mental health challenges in the postpartum period. You are not alone. 1 Chapter 1: Introduction 1.1 Postpartum Depression and Anxiety 1.1.1 Prevalence and Impact Postpartum Depression (PPD) is a leading cause of maternal morbidity and mortality, indiscriminately affecting birthing persons worldwide (Oates, 2003). In 2019, Statistics Canada reported that PPD symptoms affect 10% of Canadian women, while an additional 8% experience comorbid PPD and postpartum anxiety (PPA) symptoms, and another 5% experience symptoms of PPA only (Government of Canada, 2019). However, this prevalence rate for PPA may be an underestimate. A recent meta-analysis found the prevalence of PPA to be higher than Statistics Canada reports, with 18% of women meeting criteria for at least one anxiety disorder in the postpartum period (Fawcett et al., 2019). As such, postpartum mental illness affects a substantial number of women, and if left unaddressed, can have significant lasting impacts on a new parent and their infant (Brummelte & Galea, 2016). Untreated postpartum depression and anxiety can severely impact a parent’s mental and physical health, parent-infant bonding, offspring cognitive and motor development, and the overall wellbeing of a family unit (Agnafors et al., 2013; Beck, 1995; Brummelte & Galea, 2016; Coplan et al., 2005; 2012; Fitelson et al., 2010; Manassis et al., 1995). As they grow into adults, offspring of depressed and/or anxious parents may also experience emotional challenges, aggressive tendencies, and mental illness at higher rates than their peers (Beck, 1995; Manassis et al., 1995; Turner et al., 1987). Given the significant impacts of postpartum mental illness on birthing parents and their families, the development and 2 implementation of effective strategies for PPD and PPA detection, prevention, and treatment are critical (Zhou et al., 2022). 1.1.2 Definitions PPD is a clinical condition often requiring professional psychological intervention (Gavin et al., 2005). In the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013), PPD is defined as a depressive episode with onset up to four weeks postpartum, although, clinically, PPD may present at any time from birth until 12 months postpartum (Brummelte & Galea, 2016; Wisner et al., 2013). The signs and symptoms of PPD are similar to those presented in major depressive disorder including persistent low mood, anhedonia, sleep disturbances, diminished libido, appetite changes, low energy, and in some cases, suicidal ideation (American Psychiatric Association, 2013). In addition to depression, some birthing persons also experience comorbid anxiety symptoms, while others experience anxiety symptoms only (Government of Canada, 2019). Specific anxiety and related disorders include generalized anxiety disorder, posttraumatic stress disorder, obsessive compulsive disorder, specific phobia, agoraphobia, social phobia, acute stress disorder, and/or panic disorder (American Psychiatric Association, 2013; Fawcett et al., 2019). Given the presence of somatic symptoms commonly associated with having a new infant (e.g., fatigue, weight fluctuations, sleep disturbances), some cases of postpartum mental illness are dismissed as normal consequences of childbirth, making screening, diagnosis, and subsequent treatment delivery difficult (Brummelte & Galea, 2016; Iliadis et al., 2018). 3 1.1.3 Gender Diversity Considerations It should be noted that not all those who give birth identify as women or as mothers (Rioux et al., 2022a). Gender-diverse individuals (e.g., trans and non-binary persons), whose gender identity is not congruent with their assigned sex at birth can also become pregnant and experience postpartum depression and anxiety (Rioux et al., 2022a). Recent research suggests that gender-diverse individuals desire to have children and become pregnant at similar rates to cisgender persons (Gedzyk-Nieman & McMillian-Bohler, 2022; Greenfield & Darwin, 2021). Due to a lack of empirical research on gender diversity and perinatal mental health, the exact prevalence of PPD and PPA in gender-diverse birthing parents is unknown (Greenfield & Darwin, 2021). However, it is thought that gender-diverse populations may face increased vulnerability to perinatal mental health difficulties given that trans and non-binary people are more likely to be underserved by healthcare systems and experience discrimination during the perinatal period (Gedzyk-Nieman & McMillian-Bohler, 2022; Greenfield & Darwin, 2021). As much of the body of literature describing perinatal mental health remains centered on cisgender women (i.e., those whose gender identity corresponds with their sex assigned at birth), it is important to seek to include gender-diverse individuals within perinatal mental health research to further understand how these populations are affected by perinatal mental health concerns (Greenfield & Darwin, 2021; Rioux et al., 2022a; Rioux et al., 2022b). One recommended way to promote gender inclusivity is through language and terminology (Rioux et al., 2022b). In accordance with this recommendation, we elected to use gender neutral language or to use the gender inclusive term “birthing person” in lieu of the terms “woman” or “mother” throughout the current intervention and within all study protocols and recruitment materials. 4 1.1.4 Current Treatments Numerous effective options exist for the prevention, management, and treatment of PPD and PPA (Fitelson et al., 2010). These include psychological approaches such as cognitive behavioural therapy (CBT), person-centered therapy, behavioural activation, interpersonal psychotherapy, peer support techniques, self-care, and psychoeducational interventions (Fitelson et al., 2010). Current literature supports the use of psychological interventions as first-line management options for perinatal depression and anxiety with CBT being the most evidence-based psychological intervention (Branquinho et al., 2021; Cuijpers et al., 2023). The use of pharmacological treatments, namely selective serotonin reuptake inhibitors (SSRIs) and norepinephrine-dopamine reuptake inhibitors (NDRIs), is also supported by a strong evidence base for PPD and PPA treatment, though perinatal persons are reported to largely prefer nonpharmacological approaches in part due to perceptions of potential safety concerns associated with breastfeeding and medication use (Dennis & Chung-Lee, 2006; Fitelson et al., 2010; Goodman et al., 2014). Currently, best practice guidelines for perinatal mental healthcare within British Columbia (BC) recommend management based on symptom severity (Williams et al., 2014). In accordance with the literature, nonpharmacological interventions such as psychotherapies, self-care, and psychoeducation are typically recommended as first-line options before considering pharmacological treatment for mild-to-moderate cases (Cuijpers et al., 2023; Williams et al., 2014). Psychoeducation in particular, which involves the provision of evidence-based psychological health information, is suggested as fist-line intervention for the prevention and management of mild-to-moderate perinatal mental health conditions, or in conjunction with other 5 evidence-based treatments (e.g., psychotherapy and/or pharmacotherapy) for moderate-to-severe cases (Donker et al., 2009; Williams et al., 2014). 1.1.5 Barriers to Accessing Care Despite the availability of effective management options, several barriers exist preventing birthing persons from accessing the mental health support they need (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). The literature points to social stigma, financial constraints, insufficient education and awareness, and logistical issues with attending in-person appointments as some of the main barriers impacting help-seeking behaviours in those affected by postpartum mental illness (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). Social stigma, introduced by societal and/or cultural norms, can induce fears of being judged as a “bad parent” for struggling with mental health during the postpartum period, a time that is overwhelmingly portrayed as positive and joyful (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). These feelings of shame and guilt often prevent new parents from disclosing symptoms of depression and anxiety, leading to reduced help-seeking behaviours (Dennis & Chung-Lee, 2006; Milgrom et al., 2016). Financial barriers present further accessibility issues for new parents seeking mental health treatment (Dennis & Chung-Lee, 2006; Hanley et al., 2018; Jones, 2019). For example, a 2018 study conducted in BC found a significant association between lower socioeconomic status and reduced access to professional psychological and pharmacological support in perinatal populations, as women in the lowest income quintile were less likely than those in the highest income quintile to see a psychiatrist and be prescribed antidepressants to treat mental health concerns (Hanley et al., 2018). This finding suggests that the disparity in access to mental health 6 treatment may be due to economic factors including high costs of specialist mental health practitioners, decreased income due to time off work, and constraints in finding affordable childcare to attend appointments (Dennis & Chung-Lee, 2006; Hanley et al., 2018; Jones, 2019). In addition, commonly recommended psychotherapeutic treatments, such as CBT, are known to be time consuming and expensive and have yet to be broadly publicly funded in BC, presenting another key financial barrier to evidence-based mental healthcare (Fawcett et al., 2019). Further, insufficient awareness and education related to postpartum mental illness has been identified as a key element in limiting access to care (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). Knowledge gaps exist both for patients and care providers, rendering new parents unable to recognize the signs and symptoms of postpartum depression and anxiety (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). This lack of awareness can lead to birthing parents remaining undiagnosed for extended periods of time, which can exacerbate mild (and perhaps preventable symptoms) into much more significant ones (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). As time passes, individuals may then face greater provider barriers and wait times that further impede help-seeking (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). Untreated PPD increases the risk for depression beyond the postpartum period with women experiencing approximately six times the risk for depression later in life in comparison to women who did not suffer PPD (Josefsson & Sydsjö, 2007). Finally, logistical issues in attending in-person appointments introduce further challenges, especially for those located in rural and remote areas (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). With the majority of care options concentrated in urban centres, many families face difficulties managing long commute times and finding accessible 7 transportation on top of the existing logistics associated with attending appointments with a newborn (Milgrom et al., 2016). 1.2 eHealth eHealth involves the translation of health interventions from traditional in-person provision to delivery via telephone, mobile application, or web-based platforms (Enam et al., 2018; Eysenbach, 2001). Some ways eHealth may be delivered include telephone calls, text messages, email, web-enabled therapeutic and/or educational resources, social media platforms and online chat rooms (Enam et al., 2018; Eysenbach, 2001). 1.2.1 Uses in Mental Healthcare By making information, education, and management resources available online, eHealth presents as a promising solution for increasing access to mental healthcare (Taylor & Luce, 2003; Zhao et al., 2021). A wide array of eHealth interventions have been created to address mental health conditions (e.g., depression and anxiety) in various patient populations and have been shown to effectively reduce depression and anxiety symptomatology in a way that is cost-effective and accessible for patients (Davies et al., 2014; Foroushani et al., 2011; Grist & Cavanagh, 2013; Lal, 2019; Saddichha et al., 2014; Taylor & Luce, 2003). Specific features and modalities of eHealth-delivered mental health interventions vary widely, and may include educational materials, screening tools, symptom tracking, social networking, peer support, guided or self-directed psychotherapeutic treatments, or direct therapist-delivered care (Saddichha et al., 2014). Literature describing specific factors influencing eHealth intervention effectiveness is overwhelmingly focused on resources that incorporate a direct psychotherapeutic 8 component, namely CBT-based resources (Saddichha et al., 2014). For these kinds of interventions (e.g., structured therapeutic modules), evidence suggests that effectiveness improves when therapist guidance is incorporated, as opposed to self-directed resources, though both have been shown to be effective for reducing depression/anxiety symptoms (Etzelmueller et al., 2020; Saddichha et al., 2014; Titov et al., 2013). The body of evidence describing specific factors influencing the effectiveness of eHealth interventions without direct therapeutic components (e.g., psychoeducational resources) is less well-established, though it has been suggested that user interactivity and provision of evidence-based information may be important factors for intervention adherence and effectiveness (Donker et al., 2009; Fleming et al., 2018; Rigabert et al., 2020). 1.2.2 Examples of Uses in Postpartum Mental Health More recently, several eHealth interventions have been developed and assessed specifically to address postpartum mental health conditions and have been shown to effectively reduce symptoms of PPD and PPA (Lee et al., 2016; Milgrom et al., 2016; Ngai et al., 2015; O’Mahen et al., 2014; Pugh et al., 2016; Wozney et al., 2017; Zhao et al., 2021). For example, O’Mahen et al. (2014) evaluated NetmumsHWD, a 12-session, modular, internet behavioural-activation-based treatment for PPD, with guidance provided by telephone in 83 women in the United Kingdom, randomized to receive the intervention, or treatment as usual. PPD symptoms were measured using the Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms were measured using the Generalized Anxiety Disorder Scale (GAD-7). Authors found large and medium Cohen’s d between-group effect sizes favouring intervention participants on depression (−0.87, 95% CI [−0.42 to −1.32]) and anxiety scores (−0.59, 95% CI [−1.11 to−0.07]), compared 9 with those who received treatment as usual and effects for depression were reliably and clinically significant for over 60% of intervention participants post-treatment (according to Jacobson & Truax’s [1991] procedures for calculating reliable and clinically significant change on the EPDS) (O’Mahen et al., 2014). Another study assessed the efficacy of an internet-based CBT program for PPD, with seven therapeutic modules provided online with program support by psychology doctoral students via email (Pugh et al., 2016). In 50 Canadian women, symptoms of postpartum depression decreased more for the intervention group (average reduction of 6.24 points on the EPDS), compared to a waitlist control group (average reduction of 2.42 points on the EPDS), and results were clinically significant (measured based on calculations of Matthey’s Reliable Change Index [RCI] for the EPDS) (Matthey, 2004; Pugh et al., 2016). 1.2.3 Patient Partnership in Current Postpartum eHealth Interventions Incorporating patient partnership in research designed to develop health interventions has been shown to improve end products, as they prioritize end-users’ perspectives and centralize their lived experiences (Bashir et al., 2019; Canadian Institutes of Health Research, 2011; van Gemert-Pijnen et al., 2011). In particular, a recent study found that patient education material co-created with patients was rated as more usable and preferred to content created by professionals only (Bashir et al., 2019). As stated in the established standards for evaluating eHealth interventions, the conceptualization and design phases are key points of evaluation (Eng, 1999). Nevertheless, many eHealth interventions are only evaluated following the conceptualization and design phases, at the end of the study period (Enam et al., 2018). A user-centered design approach involves an iterative process of incorporating end-user input at each stage of 10 intervention development (Still & Crane, 2017; User-Centered Design Basics, 2017). This approach establishes the importance of understanding the identity and voice of end-users and involving them early on and regularly to design tools that are most relevant and valuable to users (Still & Crane, 2017; User-Centered Design Basics, 2017). Although existing eHealth interventions for postpartum mental health, such as those mentioned previously, have been successful in reducing symptoms of mental illness, few have taken a true user-centered approach by involving patient voices in the conceptualization and design of these platforms. For example, O’Mahen et al. (2014) utilized feedback from a qualitative study assessing women’s preferences for a perinatal CBT program when developing NetmumsHWD content. However, this feedback was not specific to the delivery of this program via eHealth and, therefore, user preferences associated with using technology for the delivery of the intervention may have been missed. As well, the Canadian eHealth intervention from Pugh et al. (2016) assessed qualitative feedback from users of their program and identified areas for improvement, but the intervention itself appears to have been conceptualized and designed by researchers only, without input from the intended user group, PPD patients. To address this gap in the literature, there is a need for research that follows a user-centered approach by involving patient partners in the initial eHealth development processes to create an intervention that best addresses the needs, values, and preferences of those facing postpartum mental illness. 11 1.3 Previous Study Phases The present study is the third phase of a multiphase research project with the overarching goal of developing an effective and accessible eHealth tool for individuals in BC experiencing postpartum mental health concerns. 1.3.1 Focus Group Study Findings In Phase One, Lackie et al. (2021) identified a need for research conducted with a user-centered design approach that involved engaging patient partners in the beginning stages of eHealth tool development to create an intervention tailored to meet the specific needs, values, and preferences of birthing parents in BC experiencing postpartum mental illness. Their study aimed to identify unmet needs of those experiencing postpartum mental illness in BC to investigate how a web-enabled intervention could best meet these needs, including the specific content and features desired. To address this, focus groups were conducted in seven communities across BC (Vancouver, Burnaby, Surrey, Kelowna, Prince George, Comox, and Victoria), and a qualitative descriptive approach was taken to identify themes inductively and thematically. A total of 31 cisgender women participated across all focus groups with a mean age of 34 years (range 24-44) and a mean of two children (range 1-3). The sample was predominantly White (81%), heterosexual (94%), highly educated (i.e., 81% completed some form of post-secondary education), and married (81%). Thematic analyses of focus group transcripts revealed five major themes: bridging gaps to meet needs; providing validation to combat stigma; nurturing capacity to cope, manage, and/or reach wellness; empowering people to take ownership over their mental health; and offering customization to ensure relevance. Each of these themes identified a need (e.g., nurturing capacity to cope, manage, and/or reach wellness) and a way that need could be 12 addressed though an eHealth intervention (e.g., providing evidence-based information and resources). At the intersection of the five themes was a common goal of promoting agency in postpartum women so that they could determine and pursue the most relevant path to personal mental health and wellness (Lackie et al., 2021). Further, authors pointed out that many of the existing interventions for postpartum mental health relied solely on delivering psychotherapy via technology, which may not address some of the key unmet needs of women such as the provision of education using evidence-based information to address the lack of knowledge surrounding perinatal mental illness, a resource hub for accessing relevant support services, and information on self-care and peer support (Lackie et al., 2021). The authors concluded that a web-enabled psychoeducational intervention would be best suited to address the unmet needs of women in BC experiencing postpartum mental health concerns. Although psychoeducational interventions are known to serve purposes such as education and prevention, research also suggests that psychoeducation can be effective for reducing symptoms of psychological disorders including depression and anxiety and are generally less expensive, less time-consuming, more easily administered, and potentially more accessible than other psychological therapeutic interventions (Donker et al., 2009). This may be particularly relevant for those facing postpartum mental health challenges considering the added time and financial constraints associated with postpartum and early parenthood (Button et al., 2017; Dennis & Chung-Lee, 2006; Jones, 2019). The opportunity to design and develop an evidence-based psychoeducational eHealth intervention for postpartum mental health based on a principles of user-centered design was especially pressing given the overall low quality of currently available eHealth-delivered psychoeducational postpartum mental health resources and the lack of empirical evidence 13 assessing their effectiveness (Kirby et al., 2018; Zhang et al., 2017). To our knowledge, this research is the first to develop and evaluate an eHealth psychoeducational intervention designed specifically to address postpartum mental health concerns including PPD and PPA. Although there are two studies that have evaluated the effects of an eHealth-delivered psychoeducational tool on improving symptoms of PPD and/or PPA (Chan et al., 2019; Shorey et al., 2017), these studies evaluated interventions that provided information geared towards general parenting, rather than for specific postpartum mental health concerns (Chan et al., 2019; Shorey et al., 2017). Moreover, no information was provided as to whether the creation of these interventions utilized a user-centered design approach by incorporating patient partners in their conceptualization and design, further providing an impetus for the current research (Chan et al., 2019; Shorey et al., 2016). 1.3.2 Website Development Phase One of this research provided a rationale for the development of the web-enabled psychoeducational intervention, PostpartumCare.ca, based on the needs and preferences expressed in focus groups (Lackie et al., 2021). To ensure that end-users’ voices were centered in the decision making throughout the development process, web design was guided by a multidisciplinary advisory committee of patient partners, mental health clinicians, researchers, and a community organization partner, all with firsthand expertise in dealing with perinatal mental illness personally and/or professionally. Web development committee members met on a bi-weekly basis from June 2020 to April 2021 with the goals of: (1) informing the development of a relevant, accessible, and acceptable web-based resource for postpartum mental health; (2) ensuring that patient needs and preferences are centred in all decision-making processes, based 14 on focus group study data and feedback from members who were patients, or who worked with patients; and (3) designing a platform that allowed for scalability, both in terms of content and population. All PostpartumCare.ca content was reviewed by the advisory group and feedback on navigating the initial (beta) version of the website was incorporated in the design. 1.3.3 Feasibility Study Findings Phase Two of this program of research involved a user involvement feasibility study to determine the content and design preferences of those who had previously experienced postpartum mental illness in a convenience sample of nine women (recruited from the sample of women who participated in previous focus groups and online via community Facebook groups) (Siddhpuria et al., 2022). Website prototypes were created to mimic PostpartumCare.ca that included content and design elements of the website as well as specific content sections including Education, Resources, and Supports. Semi-structured interviews and online surveys were used to collect feedback from participants regarding visual layout, content, and overall satisfaction with the website. Included women were an average age of 37.2 years old, with an average of 2 children per participant. All women were heterosexual and married, and the majority were White (78%) and had completed some form of postsecondary education (88%). Authors identified six key themes of content preferences including inefficacy of text-heavy layouts, highlighting key information, clarity/understandability of language, finding support groups, validation, immediate help for feelings of isolation, and helpfulness and accessibility of the resource (Siddhpuria et al., 2022). From website section page prototypes, nearly all participants either agreed or strongly agreed (89%-100%) that the layout, language, and content were found to be generally easy to understand, clear, trustworthy, and helpful to people 15 experiencing postpartum mental illness and their supports (Siddhpuria et al., 2022). Section-specific feedback showed that all participants agreed or strongly agreed that the purpose of the Education and Resources sections were clear and nearly all participants (89%-100%) indicated that the information in these sections would be relevant and helpful for people experiencing postpartum mental illness. A majority of participants (75%) agreed or strongly agreed that the purpose of the Supports section was clear and most (55%-67%) found that its contents would be relevant and helpful to people experiencing postpartum mental illness (Siddhpuria et al., 2022). This feedback was incorporated in the website design, guided by the web development advisory committee. Results from the first two phases of research provided the basis for the current Phase Three study: a randomized trial to evaluate effectiveness and usability of an initial (beta) version of PostpartumCare.ca, incorporating the themes and priorities set by the desired end-users: postpartum individuals in BC experiencing mental health concerns. 1.4 Objectives and Hypotheses The current study aimed to evaluate the effectiveness, usability, and user satisfaction of PostpartumCare.ca, a psychoeducational web-enabled resource for postpartum mental health, created based on the needs, values, and preferences of individuals in BC affected by symptoms of postpartum mental illness. This study followed a randomized controlled trial design with a waitlist control group and was conducted according to principles of effectiveness/pragmatic trials which assess whether an intervention works under typical “real-life” conditions and according to outcome measures that are relevant to the patient population (rather than assessing its efficacy under ideal or selected conditions) (Kim, 2013). Effectiveness was evaluated using primary 16 outcomes of PPD and PPA symptoms. Secondary outcomes included user ratings of website usability and satisfaction (i.e., website global patient impression, usability, understandability, actionability, technical adequacy, content quality, and appearance), and website metrics collected to gain an understanding of participant usage patterns. We hypothesized that: (1) following a four-week usage period of PostpartumCare.ca, intervention participants would see a greater reduction in depression and anxiety symptoms compared to waitlist control participants and that this would be maintained after a two-week follow-up period. (2) We also expected that PostpartumCare.ca would be rated favourably by intervention participants according to secondary outcome measures of usability and satisfaction (i.e., website global patient impression, usability, understandability, actionability, technical adequacy, content quality, and appearance). 17 Chapter 2: Methods 2.1 Participants 2.1.1 Inclusion Criteria To meet inclusion criteria participants were required to be 19 years of age or older, have given birth within the past 12 months, reside in BC, have occasional or regular access to the internet (via computer, smartphone, tablet, etc.), be able to communicate in English (i.e., be able to read, write, and speak conversational English), and be experiencing symptoms of postpartum depression and/or anxiety as per the EPDS for depression (receive a score ≥ 9), and the Perinatal Anxiety Screening Scale (PASS) for anxiety (receive a score ≥ 26) (Cox et al., 1987; Somerville et al., 2014). We focused solely on BC-based participants given that previous focus groups and feasibility testing were conducted for BC-based participants only. As such, much of PostpartumCare.ca’s content (i.e., information and resources provided) are specific to those living within the province. Potential participants of any gender were eligible so long as they were the birthing parent. No additional exclusion criteria outside of not meeting inclusion criteria were defined. Eligibility was evaluated online using a self-report eligibility questionnaire housed by a secure survey tool, Qualtrics, which complies with the BC Freedom of Information and Protection of Privacy Act (1996) as the survey data is kept secure and is stored and backed up in Canada (see eligibility questionnaire included in Appendix B1). 18 2.1.2 Recruitment Protocol for this trial was preregistered on NIH U.S. National Library of Medicine, ClinicalTrials.gov as of May 2022, prior to starting recruitment (ID No. NCT05382884). Research Ethics approval for this study was obtained from the University of British Columbia and BC Children’s and Women’s Hospital Research Ethics Board (REB number: H21-01379). Additional harmonized ethics approval was obtained from Fraser Health Authority (FHA), Interior Health Authority (IHA), Northern Health Authority (NHA), and Island Health Authority (VIHA) research ethics boards for the purposes of extending recruitment reach across multiple BC health authorities. Participants were recruited primarily online, through advertisements posted on social media pages created for the study (Facebook and Instagram), and within local BC-based Facebook groups. Online advertisements were also shared on the websites and/or social media pages of the Women’s Health Research Institute, the University of British Columbia Sexual Health Research Laboratory, and on REACH BC (an online research hub for former patients of health services in BC). In addition, community partner organizations across BC shared recruitment information via newsletters, webpages, social media, and by word of mouth with teams of clinicians working within perinatal healthcare. These community partners included Reproductive Mental Health at BC Women’s Hospital, BC Mental Health and Substance Use Services, Baby’s Best Chance (a pregnancy outreach program based in Fort St. John), Bellies 2 Babies (provided by the Kootenay Kids Society), Mothercare Pregnancy Support (provided by North Kootenay Lake Community Services Society), Patient Voices Network (administered by BC Patient Safety and Quality Council), and the Interior Health Maternal Newborn Accreditation Clinical Committee. Posters were also printed and disseminated to 19 clinicians at Reproductive Mental Health at BC Women’s Hospital. Recruitment materials are included in Appendix A. 2.1.3 Power and Sample Size Sample size was determined for a two-way mixed ANOVA with two groups and three times of assessment using G*Power software (version 3.1) with a goal of detecting a small-to-medium effect using a significance level α = 0.05 and a minimum power of 80%. A small-to-medium effect size was selected based on previous research that assessed similar interventions in postpartum populations (Chan et al., 2019; Donker et al., 2009; Faul et al., 2007; Milgrom et al., 2016; Ngai et al., 2015; Liu et al., 2022; Sawyer et al., 2019). With these parameters, the recommended total sample size was N = 74 (Kang, 2021). Considering an expected attrition rate of 20% (as per Ngai et al., 2015 and O’Mahen et al., 2014), we aimed to enroll a minimum of 93 participants. 2.2 Procedures 2.2.1 Screening and Enrollment This study was conducted entirely online, with all materials accessible through any computer, tablet, or smartphone. Online advertisements linked potential participants to an initial eligibility screening questionnaire housed by the secure survey tool, Qualtrics. If eligible, potential participants were prompted to download and read the study consent form, provide contact information (email and phone number), and complete a demographics questionnaire. Potential participants were then given 24-48 hours to review the consent information. After this 20 time period, the study coordinator or a research assistant contacted the potential participant by phone to discuss the consent form and answer any study-related questions. If they chose to participate, consent was obtained verbally. 2.2.2 Randomization Immediately after obtaining verbal consent by phone, eligible participants were randomized to either the intervention, or the waitlist control group. Simple randomization was conducted using Google’s random number generator (0 – waitlist control, 1 – intervention). Upon randomization, participants were not notified of their group allocation, they were only notified via email of when their start date would be for website access. Randomization procedures and enrolment of participants were conducted by the study coordinator, who was the sole person with knowledge of participants’ group allocation. 2.2.3 Intervention and Waitlist Control Conditions Participants in the intervention group received access to the beta version of the PostpartumCare.ca website immediately following the completion of baseline questionnaires. PostpartumCare.ca is composed of a main landing page containing tabs for three main website sections: Education, Resources, and Supports, as well as a separate Mood/Anxiety Tracker section. The Education, Resources, and Supports sections house information related to PPD and PPA, links to local BC and remote (online/phone) support services, and information on social supports and self-care practices, respectively. The Mood/Anxiety Tracker section permits users to sign in and input mood and/or anxiety symptoms to track symptom changes over time. Upon clicking on the Mood/Anxiety Tracker tab, users are prompted to create a unique username and 21 password and sign in to obtain access to their individual Mood/Anxiety Tracker account. Once signed in, users can click either a “Mood” or “Anxiety” or tab and are prompted to rate their mood (i.e., how you feel most of the day, over the past week) on a sliding scale from 0 to 10, with higher scores indicating better mood, and/or their anxiety symptoms (i.e., how anxious you feel most of the day, over the past week) on a sliding scale from 0 to 10, with higher scores indicating less anxiety. For each entry, users are also given options to click on specific symptoms experienced (e.g., losing interest in favourite activities, losing ability to concentrate, often feeling guilty or worthless, etc.) and/or write an extra note in an open textbox before submitting their entry. Once submitted, users can click on a Graphs tab to see their mood/anxiety ratings plotted over time (e.g., over 3 days, 7 days, 14 days, or 30 days) or on a Resources tab for links to resources provided based on specific symptoms entered. The addition of the Mood/Anxiety Tracker section took place following the second phase of this research, based on specific focus group findings and recommendations from the web development advisory committee to better facilitate user self-reflection and empowerment/ownership over their mental wellness journey (Lackie et al., 2021). All website sections also contained links to outsources (e.g., other websites/resources) relevant to the material within each section. See Table 1 for a detailed description of website content according to section. PostpartumCare.ca was made to be accessible on any computer, tablet, or smartphone device to allow for use on any personal devices (e.g., smartphones or laptops) or public devices (e.g., library computers). Desktop and smartphone website interfaces are displayed in Figures 1 and 2, respectively. Intervention participants were notified of all website sections, given a brief description of their contents, and given four weeks to use the website as often/in whatever capacity desired with the knowledge that they would be asked to complete online questionnaires 22 evaluating their experience using the website after this four-week period. Having participants use the website as desired (i.e., without specific time and/or frequency requirements) was intended to reflect what the realistic use of the website might be for BC’s postpartum population in accordance with principles of effectiveness/pragmatic trials (Kim, 2013). As the website was password protected for the duration of the study, intervention participants were given a passcode and instructions for accessing the website via email at the beginning of their four-week usage period. Participants in the waitlist control group did not receive website access until the end of the study period, following all data collection. Participants in both groups were provided an honorarium of $25 CAD in Amazon e-gift cards per questionnaire completed throughout the study (for a total of $75 CAD). 23 Table 1 Description of Website Content by Section Website Section Content Description Education • Introduction to perinatal mental health, definitions of PPD/PPA, differences between normal and serious symptoms, and types of perinatal anxiety disorders • Information on causes and protective factors for perinatal mental illness (e.g., biological and psychosocial risk factors; added risk factors for Indigenous populations, partners, and newcomers to Canada) • Information on screening and diagnosis of perinatal mental illness (e.g., who to see for diagnosis, who should be screened, how screening works), and descriptions of treatment and management options (e.g., psychotherapy, psychoeducation, medication, mindfulness, etc.) • Additional considerations including information on perinatal mental health and pregnancy loss/stillbirth, surrogacy, LGBTQIA2S+ populations, cultural impacts and traditional practices, adoptive parents, and differences of grief vs. depression • Frequently asked questions regarding perinatal mental health (e.g., “What does perinatal mean?”, “Can I recover from PPD?”, “I don’t want to take medications, are there alternative options?”, etc.) Supports • Information on self-care practices, accessing/ building social networks and community groups, and connecting with friends and family • *Shared stories of four women’s experiences with PPD/PPA Resources • Links to in-person and remote (online/phone) resources for perinatal mental health based on geographic location within BC • Map feature with BC-based resources pinned based on geographic location • Specific resources for general perinatal mental health support, crisis services, province-wide resources, resources that require referral by a physician, and resources for partners Mood/Anxiety Tracker • Separate sign-in page to access mood/anxiety tracking feature • Mood Tracker is comprised of three entry options: (1) option to enter mood rating on a sliding scale from 0 to 10, with higher scores indicating better mood; (2) option to click on specific symptoms experienced; (3) option to enter a note relating to mood in textbox • Anxiety Tracker is also comprised of three entry options: (1) option to enter anxiety rating on a sliding scale from 1 to 10, with higher scores indicating less anxiety; (2) option to click on specific symptoms experienced; (3) option to enter a note relating to anxiety in textbox • Links to resources are provided based on entry of specific symptoms experienced once an entry is submitted • Graph is available to visualize tracked mood/anxiety ratings over time (e.g., over 3 days, 7 days, 14 days, or 30 days) Note: BC = British Columbia; LGBTQIA2S+ = Lesbian, Gay, Bisexual, Transgender, Queer and/or Questioning, Intersex, Asexual and/or Aromantic and/or Agender, Two-Spirit + (using + at the end of the acronym aims to acknowledge that many sexually and gender diverse people don't identify with the terms included in the acronym); PPA = Postpartum Anxiety; PPD = Postpartum Depression. *Stories were shared anonymously by four women who took place in previous focus group research. 24 Figure 1 Desktop Interface of PostpartumCare.ca Figure 2 Smartphone Interface of PostpartumCare.ca 25 2.2.4 Data Collection Timepoints Each arm of the study was six weeks in length and participants in both groups completed online questionnaires evaluating PPD and PPA symptoms at three time points: (T1) at baseline, prior to the intervention/waitlist control period; (T2) after the four-week intervention/waitlist control period; and (T3) after a two-week follow-up period. Each questionnaire took approximately 5-15 minutes to complete. At T2, intervention participants completed an additional questionnaire assessing website usability and satisfaction. Questionnaire links were disseminated to participants via email, then participants completed all questionnaires online using Qualtrics. Questionnaires assessing PPD/PPA symptoms and website usability and satisfaction are included in Appendix B2 and Appendix B3, respectively. For those who were late to answer questionnaire notification emails, the study coordinator followed up a total of five times (three times via email and twice via phone) to attempt to contact the participant and remind them to complete their questionnaire. If all five contact attempts were unsuccessful, the participant was deemed lost to follow-up. 2.2.5 Ethical Considerations It should be noted that this study involved participants from a particularly vulnerable population. If potential harms were disclosed by participants (i.e., if they responded to item 10 on the EPDS with a response of 1, 2, or 3, indicating suicidality risk as per the 2015 Perinatal Services BC EPDS Scoring Guide), the study coordinator reported concerns to the study principal investigator, Dr. Lori Brotto, who is a Registered Psychologist in BC. The principal investigator then followed up within 24 hours of disclosure to complete a suicide risk assessment by phone and to create a plan for safety as necessary. Resources for those in immediate need of 26 support while using the website were provided by clicking a crisis resources banner on the main landing page of PostpartumCare.ca. Additionally, all those who completed the initial eligibility screening questionnaire were provided access to a list of mental health resources available online and within BC. 2.3 Measures 2.3.1 Demographic Characteristics Demographic information was obtained through an investigator-derived self-report questionnaire. The demographic questionnaire collected information related to participants’ personal life experiences including data on socioeconomic status, intimate and family relationships, and previous mental health and medical history. Specific demographic variables collected included: age, sex, gender, relationship status, ethnicity, Indigenous identity, sexual orientation, annual household income, employment status, educational level (including highest educational level achieved and number of years of school), region of residence within BC, number of people living in the household, number of children and ages of children, number of pregnancies, number of live births, number of still births, number of infant losses, number of abortions, number of miscarriages, type of most recent pregnancy (singleton or multiple), type of most recent delivery (vaginal or planned/emergency cesarian section), location of most recent delivery (home or hospital), ability to receive perinatal care within the community of residence, PPD diagnosis by a healthcare professional and number of PPD diagnoses, PPA diagnosis by a healthcare professional and number of PPA diagnoses, as well as medication use (see Appendix B1 for full demographic questionnaire). 27 2.3.2 Primary Outcome: PPD Symptoms Edinburgh Postnatal Depression Scale (EPDS): PPD symptoms were measured using the EPDS, a standard self-report scale used internationally to evaluate PPD symptoms and recommended for screening of all postpartum parents who give birth in BC (Cox et al., 1987; Williams et al., 2014). It should be noted that the EPDS itself is not a diagnostic tool (the gold-standard being diagnostic interviews based on DSM-5 criteria) and is more appropriately used to screen for likelihood of depression in postpartum populations (Williams et al., 2014). However, an EPDS score >12 is generally accepted as a clinically significant cut-off point indicating a higher likelihood of a diagnosis for major depression in English speaking postnatal women (Matthey, 2004). The EPDS is composed of 10 items on a Likert scale from 0 to 3. Individual items are summed, and total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms. According to the EPDS scoring guide provided by Perinatal Services BC (2015), scores ≤8 indicate that depression is unlikely, 9-11 indicate possible depression, 12-13 indicate a fairly high possibility of depression, and 14 or higher indicate probable depression (Williams et al., 2014). In an attempt to avoid false negatives and include all participants who might meet PPD diagnostic criteria (i.e., scores indicate possible depression), a cut-off score of ≥9 was used as an inclusion criterion for this study (Levis et al., 2020; Williams et al., 2014). Cronbach’s alpha for the present sample was .85, indicating a high level of internal consistency (DeVellis, 2003; Kline, 2005). 28 2.3.3 Primary Outcome: PPA Symptoms Perinatal Anxiety Screening Scale (PASS): PPA symptoms were measured using the PASS, a reliable and valid 31-item self-report measure for anxiety screening in perinatal populations (Somerville et al., 2014). The PASS is not a diagnostic tool for PPA, rather, it differentiates between high and low risk of presenting with an anxiety disorder (Somerville et al., 2014). At present, the PASS has yet to be validated as a screening tool for perinatal anxiety and related disorders and, therefore, it is not yet recommended for widespread implementation in clinical settings (Fawcett et al., 2019; Fairbrother et al., 2019). However, it has been validated using a cut-off score to detect risk for problematic anxiety in populations of perinatal women (Amiri et al., 2022; Jradi et al., 2020; Koukopoulos et al., 2021; Somerville et al., 2014; Yazıcı et al., 2019). Each item on the PASS is reported on a Likert scale from 0 – not at all to 3 – almost always, referring to the frequency of symptoms over the past month. Total scores range from 0 to 93, with higher scores indicating more severe anxiety symptoms. The recommended cut-off score of ≥26 was used in this study as an inclusion criterion to differentiate between high and low risk of presenting with an anxiety disorder (Somerville et al., 2014). Cronbach’s alpha for the present sample was .94, indicating a high level of internal consistency (DeVellis, 2003; Kline, 2005). 2.3.4 Secondary Outcome: Website Usability and Satisfaction Patient Global Impression of Change (PGIC): A brief 3-question PGIC questionnaire was adapted for this study based on the measure developed by Hurst and Bolton (2004) to assess perceived effects of using PostpartumCare.ca by participants. The first question (PGIC 1) evaluated participants’ perceived improvement of PPD and/or PPA symptoms asking: “To what 29 extent do you believe that there has been an improvement in your symptoms of postpartum depression and/or anxiety following the treatment you received through PostpartumCare.ca in the course of this study?”. Possible answers fell on a six-point Likert scale indicating: 1 – complete recovery, 2 – great improvement, 3 – moderate improvement, 4 – small improvement, 5 – no improvement, or 6 – deterioration. The second question (PGIC 2) evaluated perceived improvements in overall quality of life asking: “To what extent do you believe that there was an improvement in the overall quality of your life following the treatment you received through PostpartumCare.ca in the course of this study?”. Possible answers fell on a 5-point Likert scale indicating: 1 – great improvement, 2 – moderate improvement, 3 – small improvement, 4 – no improvement, or 5 – deterioration. The third question (PGIC 3) rated overall satisfaction towards the intervention by asking: “Please rate, on a scale from 0 – completely dissatisfied to 10 – completely satisfied, your global satisfaction towards the treatment you received with PostpartumCare.ca.”. Possible answers were reported on a numerical scale from 0 – completely dissatisfied to 10 – completely satisfied. System Usability Scale (SUS): The SUS is a reliable tool used for measuring system usability of a wide variety of products and services (e.g., mobile devices, websites, and applications) (Brooke, 1995). It consists of a 10-item questionnaire with five Likert scale response options from 0 – strongly disagree to 4 – strongly agree. Items indicated usability parameters such as website ease of use, complexity, function integration, etc. For this study, the SUS was modified by replacing the word “system” in each question with “website” to increase clarity for participants. For positively worded items (i.e., 1,3,5,7,9) the total score contribution is equal to the scale position minus 1. For negatively worded items (i.e., 2,4,6,8,10) the contribution is equal to 5 minus the scale position. Scores are then summed and multiplied by 2.5 30 to obtain the final SUS percentile ranking, which can range from 0 to 100, with higher scores indicating better usability. Any SUS score ≥68 is considered to be above average (Bangor, 2009; Brooke, 1995). Patient Education Materials Assessment Tool (PEMAT): The PEMAT reliably and validly evaluates and the understandability and actionability of patient education materials using a 24-item questionnaire (Shoemaker et al., 2014). Understandability is defined as the degree to which consumers of diverse backgrounds and varying levels of health literacy can process and explain key messages of patient education materials (Shoemaker et al., 2014). Actionability is defined as the degree to which consumers of diverse backgrounds and varying levels of health literacy can identify what they can do based on the information presented by patient education materials (Shoemaker et al., 2014). Possible answers are binary and correspond to either 1 point – agree, or 0 points – disagree. The PEMAT provides two separate scores for each material it evaluates, one for understandability and a separate score for actionability (Shoemaker et al., 2014). The first 17 items are summed and divided by the total possible points and then multiplied by 100 to achieve a final percentage score for understandability. The remaining items are also summed, divided by the total possible points, and multiplied by 100 to achieve a final percentage score for actionability. Higher scores indicate more understandable and/or actionable materials (Shoemaker et al., 2020; Shoemaker et al., 2014). User-Perceived Web Quality Instrument (UPWQI): The UPWQI is a 25-item instrument that measures four dimensions of perceived web quality: technical adequacy (e.g., webpage loading speed and ease of navigation), content quality (e.g., clarity, usefulness, and accuracy of website information), specific content (e.g., finding information related to user policies, products/services, and contact information), and appearance (e.g., attractiveness, use of 31 colours/fonts, and organization), developed and validated by Aladwani and Palvia (2002). All items are measured on a Likert scale from 1 – strongly disagree to 7 – strongly agree (Aladwani & Palvia, 2002). For this study, participant scores for items of each dimension were summed, then divided by the number of items corresponding to that dimension. Final scores ranged from 1 to 7 and higher scores indicated better web quality ratings on all four dimensions. 2.3.5 Secondary Outcome: Website Metrics Website metrics were collected at T2 to describe how intervention participants used PostpartumCare.ca. Website metrics were separated by the four main website sections (Education, Resources, Supports, and Mood/Anxiety Tracker) and included average number of page visits per participant, average time spent visiting each section per session (in minutes), total number of pageviews, and most visited outsources. These metrics were measured for each group, as such, individual level user engagement was not obtained. Website metrics were collected using Matomo Analytics, a plugin for websites hosted by WordPress (the hosting platform for PostpartumCare.ca) to gain an understanding of what realistic usage patterns might be for those accessing the website (i.e., if, how much, and to what extent, different sections were accessed). 2.4 Data Analysis Plan 2.4.1 Statistical Analyses Outcome data were analyzed following intention-to-treat (ITT) principles given that randomized participants were analyzed according to their allocated group. To assess differences in baseline demographic characteristics between intervention and waitlist control groups, 32 independent t-tests were conducted for all continuous variables and chi-square tests were conducted for all categorical variables. Independent t-tests were also conducted to evaluate differences in baseline PPD (EPDS) and PPA (PASS) total scores. To evaluate primary outcomes of postpartum depression and anxiety symptoms, two-way mixed ANOVAs with one between subject factor (group: intervention, waitlist control) and one within subject factor (time of assessment: T1, T2, T3) were conducted. Data for primary analyses met assumptions for conducting ANOVAs (reported in Appendix C1). Results of participant demographic questionnaires and secondary outcome measures (i.e., usability and satisfaction measures and website metrics) were reported descriptively. All statistical analyses were conducted using IBM SPSS Statistics (version 28.0.1.1). 2.4.2 Missing Data For analyses of primary outcomes, the study was sufficiently powered, and missing data was low (≤5%) and satisfied MCAR (missing completely at random) assumptions according to Little’s MCAR test and visual inspections of missing value patterns. When these conditions are met, listwise deletion is known to produce unbiased estimates and conservative results (Kang, 2013; Schafer, 1999). As such, listwise deletion was used in ANOVA analyses for participants who were lost to follow-up. For individual missing data points on primary outcome scales, respondent-based mean replacement was used in the calculation of scale summary scores given that MNAR (missing not at random) was not indicated. 33 2.4.3 Calculating Clinical Significance Clinically significant improvement was assessed for both primary outcomes in addition to statistical significance. Clinically significant change on the EPDS was calculated according to procedures outlined by Matthey (2004) for RCI and cut-off analyses in participants who met the accepted EPDS cut-off score of >12 for clinical levels of depression at baseline. Matthey determined that the RCI for the EPDS is four points, which describes the size of the difference between two scores needed for a clinician to be 95% confident that the change is due to real changes in the individual, rather than error (2004). Therefore, an EPDS score decrease of four or more points from T1 to T3 indicated a reliable decrease in our study. Further, a cut-off score change from >12 to ≤12 indicates a shift from clinical levels of PPD to subclinical or non-depressed levels (Matthey, 2004). Considering both of these factors together, participants who saw a reliable score decrease and cut-off change from T1 to T3 were classified as “recovered” from PPD (as per Matthey’s procedures). A chi-square test was conducted to determine if there was an association between group and PPD recovery, signifying clinically significant improvement. Clinically significant improvement for PPA was defined as a change in PASS total scores from ≥26 to <26 from T1 to T3, as this is the recommended cut-off score for differentiating between high and low risk for presenting with an anxiety disorder (Somerville et al., 2014). Participants whose PASS scores changed from ≥26 to <26 from T1 to T3 were considered “improved” for PPA. A chi-square test was conducted to determine if there was an association between group and clinically significant improvement of PPA. 34 Chapter 3: Results 3.1 Participants 3.1.1 Retention All participants found out about and enrolled in the study via online advertisements (Facebook, Instagram, or REACH BC). A total of 487 potential participants completed or partially completed the initial screening questionnaire (see Figure 3). Of these, 159 were bot responses and 11 were duplicate questionnaires (assessed by Qualtrics reCAPTCHA scoring). Therefore, 317 were assessed for eligibility. Two hundred and fourteen were excluded, either for not meeting inclusion criteria (n = 120), declining to participate (n = 3), providing incomplete screening questionnaires (n = 42), or being unable to reach by phone to obtain verbal consent (n = 49). The remaining 103 participants provided informed verbal consent and were enrolled and randomized to either the intervention (n = 52) or waitlist control group (n = 51). Following randomization, 101 completed T1 questionnaires, 95 completed T2 questionnaires, and 92 completed T3 questionnaires and were included in analyses for primary outcomes (intervention: n = 45, waitlist control: n = 47). From randomization to T3, 11 participants were lost to follow-up as they did not respond to reminders prompting questionnaire completion, resulting in a 10.7% attrition rate. All participants (N = 103) were included in demographic characteristic analyses. All participants who completed T1 questionnaires (n = 101) were included in analyses of baseline PPD/PPA symptoms and all intervention participants who completed T2 questionnaires (n = 47) were included in analyses for secondary outcomes. 35 Figure 3 CONSORT Diagram 36 3.1.2 Characteristics Participant demographic characteristics are reported in Table 2. Although participants of any gender were eligible for inclusion in this study, all participants enrolled identified as women and were assigned female at birth (as per a self-reported questionnaire), so we refer to our sample as “women” from here on. A majority of participants were White (64.1%), non-Indigenous (90.3%), married (73.8%), heterosexual (76.7%), completed some form of post-secondary education (72.8%), earned a household income of $100,000 CAD or more (56.5%), were on maternity leave (77.7%), and lived either in BC’s Lower Mainland, Fraser Valley, or Vancouver (50.5%). For their most recent pregnancy, most had a singleton pregnancy (97.1%) delivered vaginally (55.3%) in a hospital (95.1%), and were able to receive care within their community of residence (78.6%). A majority had not been previously diagnosed with PPD (73.8%) or PPA (74.8%) by a healthcare professional and did not use medication intended to treat mental health conditions (e.g., SSRIs or NDRIs) (73.8%). The mean age of women in this study was 32.91 years, SD = 5.13. The mean number of people living in participant households was 3.87, SD = 1.16, and the mean number of children per participant was 1.69, SD = 0.95. 3.1.3 Baseline Demographic Comparisons Analyses comparing the two groups on demographic variables at T1 revealed a significant difference in age and education levels (see Appendix C2: Tables A1 and A2). Waitlist control participants (M = 34.25, SD = 4.84) were significantly older than intervention participants (M = 31.60, SD = 5.12), t(2) = 2.71, p = .008. Waitlist control participants (M = 17.64, SD = 4.84) attended significantly more years of school compared to intervention participants (M = 16.06, SD = 3.16), t(97) = 2.62, p = .010, and had attained higher education 37 levels, χ 2(6, N = 103) = 12.81, p = .046. All other demographic characteristics did not differ significantly between groups. To factor in the significant group differences in age and education at baseline, the interaction of time and group was also tested using ANCOVA with age and education as covariates. The results of ANCOVA produced the same pattern of significant interaction and time main effects for both primary outcomes and there were no significant interactions between time and covariates. Therefore, the originally planned ANOVA results are reported without age and education included. 3.1.4 Baseline PPD and PPA Symptom Comparisons Baseline total scores for PPD and PPA symptoms are presented in Table 3. Mean scores at T1 indicated that both intervention and waitlist control groups fell above the cut-off for clinical levels of depression (EPDS >12) and above the cut-off indicating high risk of presenting with a perinatal anxiety disorder (PASS ≥26) (Matthey, 2004; Somerville et al., 2014). There were no significant differences between intervention and waitlist control groups for baseline EPDS scores t(99) = 0.97, p = .335, or for baseline PASS scores t(99) = 0.80, p = .424. 38 Table 2 Demographic Characteristics of Intervention and Waitlist Control Group Participants at Baseline (T1) Measure Intervention Waitlist control Total Number of Participants, N 52 51 103 *Age (years), M ± SD 31.60 ± 5.11 34.25 ± 4.84 32.91 ± 5.13 Sex, n (%) Female 52 (100) 51 (100) 103 (100) Gender, n (%) Woman 52 (100) 51 (100) 103 (100) Relationship status, n (%) Unmarried without a partner 2 (3.8) 1 (2.0) 3 (2.9) Unmarried with a partner 5 (9.6) 2 (3.9) 7 (6.8) Married 37 (71.2) 39 (76.5) 76 (73.8) Common law 7 (13.5) 9 (17.6) 16 (15.5) Divorced 1 (1.9) 0 (0) 1 (1.0) Ethnicity, n (%) Arab/West Asian 1 (1.9) 3 (5.9) 4 (3.9) Black 4 (7.7) 1 (2.0) 5 (4.9) Chinese 6 (11.5) 7 (13.7) 13 (12.6) Filipino 0 (0) 3 (5.9) 3 (2.9) Hispanic/Latin American 1 (1.9) 4 (7.8) 5 (4.9) Korean 1 (1.9) 0 (0) 1 (1.0) South Asian 1 (1.9) 1 (2.0) 2 (1.9) Southeast Asian 1 (1.9) 2 (3.9) 3 (2.9) White 35 (67.3) 31 (60.8) 66 (64.1) Other 6 (11.5) 4 (7.8) 10 (9.7) Prefer not to answer 1 (1.9) 1 (2.0) 2 (1.9) Indigenous identity, n (%) Yes 4 (7.7) 6 (11.8) 10 (9.7) No 48 (92.3) 45 (88.2) 93 (90.3) Type of Indigenous identity, n (%) First Nations 2 (3.8) 3 (5.9) 5 (4.9) Metis 1 (1.9) 3 (5.9) 4 (3.9) Cree 1 (1.9) 0 (0) 1 (1.0) Sexual orientation, n (%) Asexual 2 (3.8) 4 (7.8) 6 (5.8) 39 Bisexual 5 (9.6) 4 (7.8) 9 (8.7) Heterosexual 41 (78.8) 38 (74.5) 79 (76.7) Pansexual 1 (1.9) 2 (3.9) 3 (2.9) Prefer not to answer 3 (5.8) 3 (5.9) 6 (5.8) Annual household income (CAD), n (%) Less than $20,000 2 (3.8) 1 (2.0) 3 (2.9) $20,000-$39,999 4 (7.7) 2 (3.9) 6 (5.8) $40,000-$59,999 3 (5.8) 4 (7.8) 7 (6.8) $60,000-$79,999 5 (9.6) 5 (9.8) 10 (9.7) $80,000-$99,999 9 (17.3) 5 (9.8) 14 (13.6) $100,000-$119,999 4 (7.7) 10 (10.6) 14 (13.6) $120,000-$139,999 6 (11.5) 6 (11.8) 12 (11.7) $140,000-$159,999 8 (15.4) 3 (5.9) 11 (10.7) More than $160,000 6 (11.5) 9 (17.6) 15 (14.6) Prefer not to answer 5 (9.6) 6 (11.8) 11 (10.7) Employment status, n (%) Full time 3 (5.8) 3 (5.9) 6 (5.8) Part time 1 (1.9) 1 (2.0) 2 (1.9) On disability 3 (5.8) 0 (0) 3 (2.9) On maternity leave 41 (78.8) 39 (76.5) 80 (77.7) Self-employed 0 (0) 1 (2.0) 1 (1.0) Stay-at-home caregiver 2 (3.8) 4 (7.8) 6 (5.8) Unemployed 0 (0) 2 (3.9) 2 (1.9) Other 2 (3.8) 1 (2.0) 3 (2.9) *Years of school, M ± SD 16.06 ± 3.16 17.64 ± 2.83 16.86 ± 3.08 *Highest education level, n (%) Attended some high school 2 (3.8) 1 (2.0) 3 (2.9) Graduated high school or earned GED 3 (5.8) 1 (2.0) 4 (3.9) Attended some college/university 11 (21.2) 9 (17.6) 20 (19.4) Graduated 2-year college/university 8 (15.4) 2 (3.9) 10 (9.7) Graduated 4-year college/university 21 (40.4) 17 (33.3) 38 (36.9) Post-Graduate degree 7 (13.5) 20 (39.2) 27 (26.2) Prefer not to answer 0 (0) 1 (2.0) 1 (1.0) aRegion of residence within BC, n (%) Interior BC 4 (7.7) 8 (15.7) 12 (11.7) Northern BC 6 (11.5) 5 (9.8) 11 (10.7) 40 Lower Mainland/Fraser Valley (not including Vancouver) 18 (34.6) 13 (25.5) 31 (30.1) Vancouver 12 (23.1) 9 (17.6) 21 (20.4) Vancouver Island 12 (23.1) 16 (31.4) 28 (27.2) Number of people living in household, M ± SD 3.88 ± 1.22 3.86 ± 1.11 3.87 ± 1.16 Number of adults (age 18 or older) living in household, M ± SD 2.25 ± 1.06 2.14 ± 0.72 2.19 ± 0.91 Number of children, M ± SD 1.67 ± 1.08 1.71 ± 0.81 1.69 ± 0.95 Ages of children, n (%) At least 1 child under 6 years of age 52 (100) 51 (100) 103 (100) At least 1 child between 6 and 12 years of age 4 (7.7) 6 (11.8) 10 (9.7) At least 1 child between 13 and 18 years of age 4 (7.7) 3 (5.9) 7 (6.8) Number of pregnancies, M ± SD 2.44 ± 2.05 2.34 ± 1.26 2.39 ± 1.69 Number of live births, M ± SD 1.62 ± 1.05 1.63 ± 0.73 1.62 ± 0.90 Number of still births, M ± SD 0.04 ± 0.19 0.06 ± 0.24 0.05 ± 0.22 Number of infant losses, M ± SD 0.00 ± 0.00 0.02 ± 0.14 0.01 ± 0.10 Number of abortions, M ± SD 0.17 ± 0.47 0.26 ± 0.52 0.21 ± 0.50 Number of miscarriages, M ± SD 0.67 ± 1.42 0.51 ± 0.76 0.60 ± 1.14 Pregnancy type (of most recent pregnancy), n (%) Singleton pregnancy 51 (98.1) 49 (96.1) 100 (97.1) Multiple pregnancy 1 (1.9) 2 (3.9) 3 (2.9) Delivery type (of most recent birth), n (%) Vaginal delivery 30 (57.7) 27 (52.9) 57 (55.3) Planned caesarian section 8 (15.4) 12 (23.5) 20 (19.4) Emergency caesarian section 14 (26.9) 12 (23.5) 26 (25.2) Ability to receive pregnancy, delivery, and/or postpartum care within the community of residence, n (%) Yes 42 (80.8) 39 (76.5) 81 (78.6) No 10 (19.2) 12 (23.5) 22 (21.4) Delivery location (of most recent birth), n (%) At hospital 49 (94.2) 49 (96.1) 98 (95.1) At home 3 (5.8) 2 (3.9) 5 (4.9) PPD diagnosis by a health professional, n (%) Yes 11 (21.2) 16 (31.4) 27 (26.2) No 41 (78.8) 35 (68.6) 76 (73.8) bNumber of PPD diagnoses, M ± SD 1.27 ± 0.47 1.31 ± 0.60 1.30 ± 0.54 PPA diagnosis by a health professional, n (%) 41 Yes 11 (21.2) 14 (28.0) 25 (24.3) No 41 (78.8) 36 (72.0) 77 (74.8) bNumber of PPA diagnoses, M ± SD 1.64 ± 1.21 1.14 ± 0.36 1.36 ± 0.86 aMedication use to treat mental health conditions such as PPD/PPA (i.e., SSRI, NDRI), n (%) Yes 15 (28.8) 12 (23.5) 27 (26.2) No 37 (71.2) 39 (76.5) 76 (73.8) Note: BC = British Columbia; CAD = Canadian Dollar; GED = General Educational Development; NDRI = Norepinephrine and Dopamine Reuptake Inhibitor; PPA = Postpartum Anxiety; PPD = Postpartum Depression; SSRI = Selective Serotonin Reuptake Inhibitor. *Significant difference between groups p < .05. aVariable was entered as a “fill in the blank” option on the demographic questionnaire. As such, it was recoded as a categorical variable to calculate descriptive statistics. bMeans and standard deviations for number of PPD/PPA diagnoses are reported for those who answered “yes” to being previously diagnosed (n = 27 for PPD; n = 25 for PPA). Table 3 Postpartum Depression and Anxiety Scores of Intervention and Waitlist Control Participants at Baseline (T1) Reported as Mean ± SD Measure Intervention Waitlist Control Total PPD (EPDS) 13.74 ± 4.70 14.62 ± 4.39 14.17 ± 4.55 PPA (PASS) 41.57 ± 14.34 43.96 ± 15.53 42.73 ± 14.90 Note: Statistics are reported for all participants who completed T1 questionnaires (intervention: n = 52; waitlist control: n = 49); EPDS = Edinburgh Postnatal Depression Scale; PASS = Perinatal Anxiety Screening Scale; PPA = Postpartum Anxiety; PPD = Postpartum Depression. 3.2 Primary Outcome Analyses 3.2.1 Effects of the Intervention on PPD and PPA Symptoms Descriptive statistics for primary outcomes, including means and standard deviations, are presented in Table 4. On the first primary outcome of PPD symptoms (EPDS total score), there was a significant main effect of time with scores decreasing over time, F(2,180) = 11.22, p < .001, partial η2 = .11, indicating a medium-to-large effect size, and a significant main effect of 42 group favouring the intervention group F(1, 90) = 5.40, p = .022, partial η2 = .06, indicating a medium effect size. Main effects were qualified by a significant interaction between group and time, F(2, 180) = 3.12, p = .046, partial η2 = .03, indicating a small-to-medium effect size (Adams & Conway, 1966). Post-hoc pairwise-comparison tests for the interaction effect revealed a significant mean difference from T1 to T2 (MD = 2.85, SE = 0.65, p < .001), with the effect remaining significant at T3 (MD = 2.96, SE = 0.73, p < .001) for the intervention group only. For the waitlist control group, the mean difference from T1 to T2 did not reach significance (MD = 0.62, SE = 0.63, p = .327), and the effect remained non-significant at T3 (MD = 1.20, SE = 0.71, p = .096) (see Appendix C3: Table A3). On the co-primary outcome of PPA symptoms (PASS total score), there was a significant main effect of time with scores decreasing over time, F(2,178) = 11.12, p < .001, partial η2 = .11, indicating a medium-to-large effect size, and a significant main effect of group favouring the intervention group F(1, 89) = 5.92, p = .017, partial η2 = .06, indicating a medium effect size. Main effects were qualified by a significant interaction between group and time, F(2, 178) = 3.79, p = .024, partial η2 = .04, indicating a small-to-medium effect size (Adams & Conway, 1966). Post-hoc pairwise-comparison tests for the interaction effect revealed a significant mean difference from T1 to T2 (MD = 7.42, SE = 1.74, p < .001), with the effect remaining significant at T3 (MD = 8.07, SE = 1.89, p < .001) for the intervention group only. For the waitlist control group, the mean difference from T1 to T2 was non-significant (MD = 1.33, SE = 1.68, p = .430), and the effect remained non-significant at T3 (MD = 2.64, SE = 1.83, p = .148) (see Appendix C3: Table A3). Graphical representations of primary outcomes are shown in Figures 4 and 5. 43 Table 4 Primary Outcomes of Postpartum Depression and Anxiety Scores by Time of Assessment and Group Reported as Mean ± SD Outcome Group T1 T2 T3 PPD (EPDS)1 Waitlist Control 14.54 ± 4.37 13.91 ± 5.24 13.34 ± 5.44 *Intervention 13.88 ± 4.86 11.02 ± 4.60 10.91 ± 4.59 PPA (PASS)2 Waitlist Control 43.74 ± 15.78 42.44 ± 15.67 41.08 ± 16.52 *Intervention 40.63 ± 13.81 33.21 ± 14.64 32.57 ± 14.08 Note: Statistics are reported for all participants who completed T3 questionnaires (intervention: n = 45; waitlist control: n = 47); Scale Range: 10 to 30; 20 to 93; For both outcomes, higher scores indicate more severe PPD/PPA symptoms; EPDS = Edinburgh Postnatal Depression Scale; PASS = Perinatal Anxiety Screening Scale; PPD = Postpartum Depression; PPA = Postpartum Anxiety. *Significant time by group interaction p < .05. Figure 4 Postpartum Depression (EPDS) Scores by Time of Assessment and Group Reported as Mean ± SE Note: Possible range of scores: 0 to 30, higher scores indicate more severe depression symptoms; EPDS = Edinburgh Postnatal Depression Scale 44 Figure 5 Postpartum Anxiety (PASS) Scores by Time of Assessment and Group Reported as Mean ± SE Note: Possible range of scores: 0 to 93, higher scores indicate more severe anxiety symptoms; PASS = Perinatal Anxiety Screening Scale 3.2.2 Clinical Significance for PPD For those who met a cut-off of EPDS >12 for clinical levels of PPD at baseline (intervention n = 30; waitlist control n = 33), scores were lowered by four or more points, indicating a reliable decrease in EPDS scores at T3 for 56.7% of intervention participants and 27.3% of waitlist controls. Additionally, 50.0% of intervention participants saw a change in EPDS scores from above the clinical cut-off of 12 to ≤12, compared to 39.4% of waitlist controls. Considering both factors together, 46.7% of intervention participants and 21.2% of waitlist controls saw a recovery from clinical PPD symptoms. A chi-square test showed a significant relationship between group and PPD recovery, such that there was a greater 45 proportion of participants recovered in the intervention group compared to the waitlist control group χ 2 (1, n = 63) = 4.58, p = .032 (see Table 5). Table 5 Comparison of PPD Recovery and Group from T1 to T3 Reported as N (%) Group aEPDS decrease ≥4 points EPDS change from >12 to ≤12 bPPD Recovery No bPPD Recovery Waitlist Control 9 (27.3) 13 (39.4) 7 (21.2) 26 (78.8) Intervention 17 (56.7) 15 (50.0) 14 (46.7) 16 (53.3) Note: Statistics are reported for participants who met clinical cut-off for PPD at baseline (EPDS >12) (n = 63); EPDS = Edinburgh Postnatal Depression Scale; PPD = Postpartum Depression. aEPDS decrease of ≥4 points equivalent to Reliable Change Index ≥1.96, indicating the change in EPDS scores is likely to be due to a real change in the individual (95% confidence). bPPD recovery indicated as both EPDS decrease ≥4 points and EPDS change from >12 to ≤12 from T1 to T3. 3.2.3 Clinical Significance for PPA At baseline, 79 participants met a cut-off of PASS ≥ 26 (intervention n = 37; waitlist control n = 42). Clinically significant improvement for PPA was defined as a change in PASS total scores from ≥ 26 to <26 from T1 to T3. By this criterion, there were more that improved in the intervention group (27%) compared to the waitlist control group (11.9%) at T3. A chi-square test showed no significant association between clinically significant PPA improvement and group, χ 2 (1, n = 79) = 2.92, p = .087 (see Table 6). Table 6 Comparison of Clinically Significant PPA Improvement and Group from T1 to T3 Reported as N (%) Group PASS change from ≥26 to 26 No PASS change from ≥26 to 26 Waitlist Control 5 (11.9) 37 (88.1) Intervention 10 (27.0) 27 (73.0) Note: Statistics are reported for participants who met the cut-off for PPA at baseline (PASS ≥ 26) (n = 79); PASS = Perinatal Anxiety Screening Scale; PPA = Postpartum Anxiety. 46 3.3 Secondary Outcome Analyses Patient Global Impression of Change: Intervention participants (n = 47) provided ratings on three questions adapted from the PGIC. On the first question evaluating perceived improvement in PPD and/or PPA symptoms following the use of PostpartumCare.ca, the mean rating was 3.74, SD = 0.94. On the second question evaluating perceived improvements in overall quality of life, participants’ mean rating was 3.06, SD = 0.73. The final question rated overall satisfaction towards PostpartumCare.ca and the mean score was 5.56, SD = 2.05 (see Appendix C4: Table A4). System Usability: Intervention participants (n = 47) rated the system usability of PostpartumCare.ca as about average overall (M = 67.29, SD = 21.15) (see Appendix C4: Table A4), given that an SUS score ≥68 indicates above average website usability (Bangor, 2009). Patient Education Materials Assessment: On average, intervention participants (n = 45) rated website understandability at 85.23%, SD = 20.63. Similarly, intervention women (n = 45) rated the website as 84.07% actionable on average, SD = 23.56 (see Appendix C4: Table A4). User-Perceived Web Quality: Intervention participants (n = 47) rated agreement with the website’s technical adequacy as M = 5.17, SD = 1.04. Agreement with Postpartumcare’s content quality was rated as M = 5.27, SD = 1.32, and specific content was rated as M = 4.97, SD = 1.15. Finally, agreement with website appearance was rated as M = 5.31, SD = 1.40 (see Appendix C4: Table A4). Website Metrics: Website metrics specific to the intervention group (n = 47) were collected according to website section (Education, Supports, Resources, Mood/Anxiety Tracker) at T2 (see Appendix C5: Table A5). The Education section was visited an average of 1.06 times per participant, for an average time of 48 minutes per session and received 56 total page views. 47 The Supports section was visited an average of 0.93 times per participant for an average time of 37 minutes per session and received 49 total page views. The Resources section was visited an average of 0.23 times per participant for an average time of 106 minutes per session and received 12 total page views. The Mood/Anxiety Tracker was visited an average of 1.02 times per participant for an average time of 33 minutes and received 82 total page views. The number of Mood/Anxiety Tracker entries per participant ranged from 0-6 total entries within the four-week study period. For those who did access the Mood/Anxiety Tracker, most participants completed between 1-3 entries. The most viewed outsources per section were: Perinatal Services BC’s health professionals page and Perinatal Services BC’s EPDS questionnaire for the Education section, PsychCentral’s self-care info blog and Pacific Postpartum Support Society’s self-care questionnaire for the Supports section, Villageofmoms.com and Postpartumdads.org for the Resources section, and PsychCentral’s self-care tips blog for the Mood/Anxiety Tracker. 48 Chapter 4: Discussion 4.1 Principal Findings The purpose of this trial was to evaluate the effectiveness, usability, and user satisfaction of PostpartumCare.ca, a web-enabled resource for postpartum mental health created based on the needs, values, and preferences of those in BC affected by symptoms of postpartum mental illness. The results supported our first hypothesis—that engagement with PostpartumCare.ca significantly reduced symptoms of PPD and PPA after four weeks in the intervention group only, with improvements maintained at the two-week follow-up point (T3). These significant improvements were associated with small-to-medium effect sizes (PPD: partial η2 = .03; PPA: partial η2 = .04). Clinically, intervention participants were also more likely than waitlist controls to recover from PPD, as indicated by crossing the clinical threshold score on the EPDS and experiencing a score decrease of four points or more. Although more intervention participants than waitlist controls moved below the threshold for clinically significant PPA improvement, improvement and group were not significantly associated. In support of our second hypothesis, PostpartumCare.ca’s usability and satisfaction were rated favourably overall by intervention participants according to secondary outcome measures. Global patient impression of change scores indicated a small-to-moderate perceived improvement in depression and anxiety symptoms, a small improvement in perceived overall quality of life, and slightly above average overall satisfaction with the intervention. System usability was rated as about average overall, understandability and actionability were highly rated, and women generally agreed with the website’s technical adequacy, content quality, specific content, and appearance. 49 Website metrics also provided some insights as to how PostpartumCare.ca may be used by BC-based women, as these metrics were collected to gain an idea of realistic usage patterns. In our study, intervention participants viewed most sections about once each on average, and spent anywhere from 33 to 106 minutes on each section per session, suggesting that realistic website visits for postpartum women may be somewhat infrequent, but of considerable duration. 4.2 Web-Enabled Psychoeducational Resource can Improve Symptoms of PPD and PPA Results from this study build upon previous research indicating that psychoeducational interventions can be effective in reducing symptoms of mental health disorders such as depression and anxiety in various patient populations and may be a valuable first-line intervention for those experiencing psychological distress (Al-Alawi et al., 2022; Chan et al., 2019; Donker et al., 2009; Williams et al., 2014). The goal of psychoeducation is to help individuals understand their symptoms and the underlying disorder, learn about available treatment options, and introduce and/or reinforce effective coping strategies (Williams et al., 2014). Several reasons have been proposed to explain the effect of psychoeducational resources on improving symptoms of depression and anxiety in the general population. First, psychoeducational resources can promote knowledge and awareness of specific mental illnesses, allowing users to feel validated in their experiences and reducing associated stigma (Al-Alawi et al., 2022; Finkelstein & Lapshin, 2007). Second, the provision of education, coping strategies (e.g., self-care techniques), and connection to further support services (e.g., local and remote mental health services) provide an opportunity for users to become partners in their mental wellness journey, reducing feelings of helplessness and increasing self-efficacy (Al-Alawi et al., 2022; Ball & Lillis, 2001; Shorey et al., 2017). Furthermore, psychoeducational resources can 50 provide support information (e.g., shared stories and social networks/community groups) which may lead to increased perceived social support—an important factor for psychological health and wellbeing (Cairney et al., 2003; Ozbay et al., 2007). The aforementioned reasons may provide an understanding as to why women in the current study saw statistically significant improvements in both depression and anxiety symptoms over time. Further, our study found evidence of the effectiveness of a psychoeducational tool for mental health delivered via eHealth and applied to a sample of postpartum women. The body of literature specifically investigating the effects of eHealth-delivered psychoeducational tools for reducing symptoms of postpartum mental illness is limited, and existing studies have shown mixed results. One study also found a reduction in PPD symptoms following the use of a smartphone-based psychoeducational intervention in first time mothers, but reductions in anxiety symptoms were not significant (Chan et al., 2019). Another study found no significant difference in PPD symptoms between intervention and control groups following the use of a psychoeducational mobile-health application, and PPA was not evaluated (Shorey et al., 2017). The current findings suggest that psychoeducational content delivered online can be an effective way to reduce symptoms of PPD and PPA in a way that is potentially more easily administered, less time consuming, and more widely accessible than many alternative pharmacological and therapeutic interventions. However, all psychoeducational resources are not created equal. Because they are informational in nature, the specific content delivered (such as the provision of evidence-based medical/psychological information geared towards depression/anxiety) may be a key factor influencing the effectiveness of psychoeducational interventions (Donker et al., 2009). It should be noted that both interventions from Chan et al. (2019) and Shorey et al. (2017) provided information related to general parenting rather than tailored to perinatal mental health 51 disorders, which might explain the inconsistency of findings in the field and provide some insights on the effectiveness of the current intervention. The fact that PostpartumCare.ca houses evidence-based information directly related to postpartum mental health concerns may indicate that women in our study responded positively to psychoeducational material specific to their underlying mental health disorder(s). Future research should therefore continue to investigate the effectiveness of web-enabled psychoeducational tools for postpartum mental health to further understand what types of information provide the most benefit to those in need of support. 4.3 User Perceptions of PostpartumCare.ca Following use of PostpartumCare.ca, participants on average perceived small-to-moderate improvements in depression and anxiety symptoms and a small improvement in overall quality of life. User feedback was positive regarding the website’s actionability and understandability, and towards specific website aspects such as technical adequacy, content quality, and appearance. These findings are in agreement with previous results from a pilot study of a prototype of the current intervention where the website’s layout, language, and content were found to be generally easy to understand, clear, trustworthy, and helpful by nearly all participants (Siddhpuria et al., 2022). However, on measures that assessed overall satisfaction and system usability, our results fell closer to average or just above average. This finding differs slightly from Siddhpuria et al. (2022), where most participants were either somewhat or very satisfied with the website protypes. A possible explanation for the more modest satisfaction ratings in the current study may be reflected in the website metrics of participants, as some key aspects of the site may not have been accessed to their fullest potential. Most pages were viewed an average of one time per participant. Because of this infrequent usage pattern, participants may not have been 52 able to fully utilize website features intended for repeated usage such as the Mood/Anxiety Tracker, which was intended to allow participants to create entries on a more regular basis to track mood and anxiety symptoms over time. However, this study did not collect direct participant feedback related to usability and satisfaction of individual website sections (i.e., Education, Resources, Supports, Mood/Anxiety Tracker) and therefore, it is difficult to confirm how satisfaction ratings might have been related to participant experiences with individual website sections/features. As such, specific reasons as to why features such as the Mood/Anxiety Tracker were not utilized as frequently as initially intended are unclear. Despite this, when considering all measures of website usability and satisfaction together, the website was reviewed favorably overall by participants in this study, evidencing its potential usefulness for women. 4.4 Taking a Patient-Centered Approach Patient-centered design puts those with lived experience at the centre of decision-making processes ensuring high relevance, acceptance and impact of an intervention (Canadian Institutes of Health Research, 2011; Still & Crane, 2017; User-Centered Design Basics, 2017). The current intervention was built upon patient engagement at each phase of its development and evaluation, consistent with principles of patient-centered design. In Phase One of this research, Lackie et al. (2021) identified unmet needs of women in BC experiencing postpartum mental illness, including a need for education, validation, empowerment, and accessible care, and found that a web-enabled psychoeducational resource would be most relevant in meeting these needs. PostpartumCare.ca was then designed based on these findings in collaboration with a web development advisory committee comprised of relevant stakeholders each with personal or professional lived experience addressing perinatal mental health concerns (e.g., patient partners, 53 mental health clinicians, researchers, and a community organizer). Then, in Phase Two, Siddhpuria et al. (2022) further engaged end-users in the evaluation of PostpartumCare.ca prototypes by soliciting specific feedback on website content and design. The current study also evaluated user feedback of website usability and satisfaction as part of a larger scale effectiveness trial. Indeed, previous research has found that materials co-created with patients are generally preferred and rated as more usable compared to those created by clinicians or researchers alone (Bashir et al., 2019; van Gemert-Pijnen et al., 2011). Despite this, few published studies evaluating digital postpartum mental health resources have incorporated the same degree of iterative and meaningful patient engagement throughout the development process (Chan et al., 2019; Fealy et al., 2019; Haga et al. 2013; O’Mahen et al. 2014; Pugh et al. 2016; Shorey et al., 2017). Considering the increasing reliance on web-enabled resources in many health domains, it is important to prioritise patient engagement given its feasibility and potential benefits for intended user populations. Our study offers evidence in support of the effectiveness and value of well-researched and patient-centered digital resources for postpartum mental health. 4.5 Clinical Implications of Findings Women with clinical levels of PPD who used PostpartumCare.ca were more likely than controls to recover from PPD after a two-week follow-up. This finding, along with the significant improvements in mean PPD symptoms that were seen in the intervention but not in the control group, suggest that our online psychoeducational resource may be a valuable tool for the alleviation of clinical PPD symptoms. For women who showed a high risk of presenting with an anxiety disorder at baseline, engagement with the intervention did not result in clinically significant improvements compared to waitlist controls, suggesting that our digital health tool 54 might not be sufficient for bringing PPA symptoms below a clinical threshold. Both of these findings, though, are difficult to confirm without the use of gold-standard methods for evaluating clinical PPD/PPA diagnosis (i.e., diagnostic interviews based on DSM-5 criteria). Therefore, future research employing gold-standard diagnostic methods is suggested to better understand the effect of a web-enabled psychoeducational tool on clinical PPD and PPA symptom recovery. Nonetheless, our results support PostpartumCare.ca’s overall effectiveness in reducing PPD/PPA symptom severity. This finding, alongside website user ratings and usage patterns suggest that women in BC would potentially use and benefit from the resource. Therefore, its use is suggested as a low-barrier first-line psychoeducational option for women in BC facing postpartum mental health concerns, or in conjunction with other evidence-based treatments (Williams et al., 2014). 55 Chapter 5: Conclusion 5.1 Limitations This study does have some limitations. First, the demographic homogeneity of our sample (e.g., in terms of gender, ethnicity, socioeconomic status, etc.) may limit the generalizability of our findings to the greater BC population, as participants were entirely cisgender-female and predominantly White, non-Indigenous, heterosexual, married, earned a household income ≥ $100,000 CAD, and most had completed some post-secondary education. While it’s possible that these data illustrate characteristics of those in BC most likely to utilize a web-enabled resource for postpartum mental health, our findings also may not be applicable to those who do not match this narrow demographic profile. Because PostpartumCare.ca is educational in nature, this lack of generalizability may be especially relevant to those who do not meet the high average educational level of study participants, as it is unclear whether those with lower educational levels would see similar symptom improvement. Further, since our study was entirely comprised of cisgender women, it is unknown whether Postpartumcare.ca would hold similar effectiveness for birthing parents who do not identify as women. Future research is therefore recommended to gain more insight as to the effectiveness of psychoeducational resources, such as the current intervention, within more diverse socioeconomic populations, particularly in terms of education and gender. Second, this study lacks longer-term follow-up periods beyond two weeks after engaging with PostpartumCare.ca, thus preventing an understanding of how depression and anxiety scores may have changed in the longer term. As such, future studies should consider extending their 56 study period and adding in multiple follow-ups to account for more precise longitudinal outcome tracking (Chan et al., 2019). Third, this study did not measure participant uses of alternate therapeutic measures for postpartum mental illness, apart from gathering medication use information upon screening and enrollment. This lack of data surrounding alternate or additional mental health supports or treatments may have made it difficult to assess the true effects of the intervention on symptom severity, introducing possible bias (Milgrom et al., 2016). For example, if intervention group participants were accessing more extensive additional supports/treatments compared to waitlist controls, this could have contributed to their symptom improvement over time and caused the effect of the current intervention to appear larger than its true effect. By contrast, if waitlist control participants were accessing more additional supports/treatments, this may have resulted in a smaller effect size compared to the true intervention effect. To address this possible bias, future studies should consider including detailed information on alternate therapeutic usage and potentially include these within statistical models as covariates to allow for a clearer picture of intervention effects, especially if support/treatment usage is found to vary significantly between groups. Finally, this study was prone to the standard limitations of online survey and self-reporting measures such as reporting and recall bias, which may have influenced participant responses (Rosenman et al., 2011). In the context of this study, participant reporting of inflated or understated PPD/PPA symptomatology (either due to errors in recall, or selective revealing and/or suppression of information) may have caused an increase or decrease in the strength of the association between intervention use and symptom improvement over time, depending on at what timepoint and/or in what group greater error was present. In future research, the risk of such 57 biases may be lessened by including additional outcome measures such as symptom assessments/diagnoses by clinicians, or diagnostic interviews. 5.2 Strengths Despite these limitations, our study had numerous strengths. First, to our knowledge this is the first study to evaluate a web-enabled psychoeducational intervention specific to the needs of women in BC affected by postpartum mental health concerns and that was designed and created in partnership with end-users according to principles of user-centered design. Although an internet search will generate several educational eHealth resources for postpartum mental health (e.g., websites or mobile applications), information is seldom provided on their development processes or evidence-based evaluation (Lackie et al., 2021). Further, existing literature points out the substandard quality of many currently available websites and apps for postpartum mental health emphasizing a critical gap in providing a comprehensive resource for postpartum mental health that is patient-centered and evidence-based, which the current intervention addresses (Kirby et al., 2018; Lackie et al., 2021; Zhang et al., 2017). Second, this study had relatively low attrition compared to similar studies in the field (Chan et al., 2019; Dennis et al., 2020), which may have been attributed to persistent follow-ups for missing study questionnaires, provision of honoraria for completion of questionnaires, or the flexibility and relatively low-demand and time commitment of the study protocol meant to allow for realistic usage of busy postpartum women facing mental health challenges. Finally, we addressed both PPD and PPA as co-primary outcomes of this study. Current literature points to a shortage of research focused on both PPD and PPA, as most of the research assessing effectiveness of eHealth-based interventions for postpartum mental health only assess 58 depressive symptoms or include anxiety as a secondary outcome (Loughnan et al., 2019). This shortage is especially troubling considering the high comorbidity of these disorders and the serious lasting psychological impacts of postpartum anxiety on women and their families if left unaddressed (Coplan et al., 2005; Fawcett et al., 2019; Firth et al., 2017; Manassis et al., 1995). 5.3 Significance and Future Directions Overall, our findings suggest that four-week usage of a web-enabled psychoeducational intervention for postpartum mental health created based on the direct input of patient partners can be effective in reducing symptoms of PPD and PPA for women in BC after a two-week follow-up period. As a follow-up to the current trial, a future knowledge translation (KT) phase will seek to develop mobilization strategies for implementing PostpartumCare.ca as a practical tool for women in BC. 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Consider participating in the SUPPORT study if you: • Are 19 years or older • Are experiencing symptoms of depression and/or anxiety • Have given birth within the past 12 months • Live in British Columbia • Are able to read and communicate in English • Have occasional or regular access to the internet via phone, tablet, or computer To see if you are eligible to participate, please click the link below and fill out the survey (this should take about 10 minutes): https://ubc.ca1.qualtrics.com/jfe/form/SV_1C9ObBViYEden1c For any general questions, or for more information, please email SUPPORTstudy@cw.bc.ca 75 A.2 Recruitment Social Media Post 76 A.3 Recruitment Poster 77 A.4 REACH BC Advertisement 78 79 80 Appendix B - Questionnaires B.1 Eligibility and Demographic Questionnaire 81 82 83 84 85 86 87 88 89 90 91 92 93 94 B.2 Depression and Anxiety Questionnaire 95 96 97 98 99 100 101 102 B.3 Website Usability and Satisfaction Questionnaire 103 104 105 106 107 108 109 110 111 112 113 114 115 Appendix C - Analysis C.1 Meeting ANOVA Assumptions In order to analyze data for primary outcomes using ANOVA, it was important that data met assumptions indicating that ANOVAs could be appropriately performed and produce valid results (Frey, 2018). Data for both primary outcomes met all important assumptions. The data was normally distributed for each combination of within- and between-subject factors, as assessed by visual inspection of Q-Q plots. There was homogeneity of variances (p > .05) and covariances (p > .05), as assessed by Levene's test of homogeneity of variances and Box's M test, respectively. Mauchly's test of sphericity indicated that the assumption of sphericity was met for the two-way interaction, for both depression χ2(2) = 2.494, p = .287, and anxiety χ2(2) = 3.677, p = .159. 116 C.2 Demographic Comparisons Tables Table A1 Independent T-Test Results Comparing Intervention to Waitlist Control Participants on Continuous Demographic Variables at Baseline (T1) Variable Intervention group Waitlist control group Statistics n M SD n M SD df t p Age (years) 52 31.60 5.11 51 34.25 4.84 101 2.71 .008 Number of years of school 49 16.06 3.16 50 17.64 2.83 97 2.62 .010 Number of people living in household 52 3.89 1.22 50 3.86 1.11 100 -0.11 .915 Number of adults (age 18 or older) living in household 52 2.25 1.06 51 2.14 0.72 101 -0.63 .531 Number of children 52 1.67 1.08 51 1.71 0.81 101 0.17 .862 Number of pregnancies 50 2.44 2.05 50 2.34 1.26 98 -0.29 .769 Number of live births 50 1.62 1.05 48 1.63 0.73 96 0.03 .978 Number of still births 52 0.04 0.19 51 0.06 0.24 101 0.48 .635 Number of infant losses 52 0.00 0.00 51 0.02 0.14 101 1.01 .315 Number of abortions 52 0.17 0.47 51 0.26 0.52 101 0.83 .407 Number of miscarriages 52 0.67 1.42 51 0.51 0.76 101 -0.72 .471 aNumber of PPD diagnoses 11 1.27 0.47 16 1.31 0.60 25 0.18 .856 aNumber of PPA diagnoses 11 1.64 1.21 14 1.14 0.36 23 -1.46 .159 Note: PPA=Postpartum Anxiety; PPD=Postpartum Depression. aStatistic is reported for those who answered yes to being previously diagnosed with PPD/PPA, rather than the whole sample of respondents. 117 Table A2 Chi-Square Test Results Comparing Intervention to Waitlist Control Participants on Categorical Demographic Variables at Baseline (T1) Variable Intervention group Waitlist control group Statistics n % n % df χ2 p Marital status 4 2.91 .573 Unmarried without a partner 2 3.8 1 2.0 Unmarried with a partner 5 9.6 2 3.9 Married 37 71.2 39 76.5 Common law 7 13.5 9 17.6 Divorced 1 1.9 0 0 aEthnicity Arab/West Asian 1 1.9 3 5.9 1 1.08 .298 Black 4 7.7 1 2.0 1 1.83 .176 Chinese 6 11.5 7 13.7 1 0.11 .738 Filipino 0 0 3 5.9 1 3.15 .076 Hispanic/Latin American 1 1.9 4 7.8 1 1.95 .162 Korean 1 1.9 0 0 1 0.99 .320 South Asian 1 1.9 1 2.0 1 0.00 .989 Southeast Asian 1 1.9 2 3.9 1 0.36 .546 White 35 67.3 31 60.8 1 0.48 .490 Other 6 11.5 4 7.8 1 0.40 .527 Prefer not to answer 1 1.9 1 2.0 1 0.00 .989 Indigenous Identity 1 0.49 .485 Yes 4 7.7 6 11.8 No 48 92.3 45 88.2 aType of indigenous identity First Nations 2 3.8 3 5.9 1 0.23 .631 Metis 1 1.9 3 5.9 1 1.08 .298 Cree 1 1.9 0 0 1 0.99 .320 Sexual orientation 4 1.22 .876 Asexual 2 3.8 4 7.8 Bisexual 5 9.6 4 7.8 Heterosexual 41 78.8 38 74.5 Pansexual 1 1.9 2 3.9 Prefer not to answer 3 5.8 3 5.9 118 Annual household income (CAD) 9 7.81 .553 Less than $20,000 2 3.8 1 2.0 $20,000-$39,999 4 7.7 2 3.9 $40,000-$59,999 3 5.8 4 7.8 $60,000-$79,999 5 9.6 5 9.8 $80,000-$99,999 9 17.3 5 9.8 $100,000-$119,999 4 7.7 10 10.6 $120,000-$139,999 6 11.5 9 17.6 $140,000-$159,999 8 15.4 3 5.9 More than $160,000 6 11.5 6 11.8 Prefer not to answer 5 9.6 6 11.8 Employment status 7 7.04 .425 Full time 3 5.8 3 5.9 Part time 1 1.9 1 2.0 On disability 3 5.8 0 0 On maternity leave 41 78.8 39 76.5 Self-employed 0 0 1 2.0 Stay-at-home caregiver 2 3.8 4 7.8 Unemployed 0 0 2 3.9 Other 2 3.8 1 2.0 Highest education level 6 12.81 .046 Attended some high school 2 3.8 1 2.0 Graduated high school or earned GED 3 5.8 1 2.0 Attended some college/university 11 21.2 9 17.6 Graduated 2-year college/university 8 15.4 2 3.9 Graduated 4-year college/university 21 40.4 17 33.3 Post-Graduate degree 7 13.5 20 39.2 Prefer not to answer 0 0 1 2.0 bRegion of residence within BC 4 3.22 .521 Interior BC 4 7.7 8 15.7 Northern BC 6 11.5 5 9.8 Lower Mainland/Fraser Valley (not including Vancouver) 18 34.6 13 25.5 Vancouver 12 23.1 9 17.6 Vancouver Island 12 23.1 16 31.4 119 aAges of children, n (%) At least 1 child under 6 years of age 52 100 51 100 At least 1 child between 6 and 12 years of age 4 7.7 6 11.8 1 0.49 .485 At least 1 child between 13 and 18 years of age 4 7.7 3 5.9 1 0.13 .715 Pregnancy type (of most recent pregnancy) 1 0.36 .546 Singleton pregnancy 51 98.1 49 96.1 Multiple pregnancy 1 1.9 2 3.9 Delivery type (of most recent birth), n (%) 2 1.10 .576 Vaginal delivery 30 57.7 27 52.9 Planned caesarian section 8 15.4 12 23.5 Emergency caesarian section 14 26.9 12 23.5 Able to receive pregnancy, delivery, and/or postpartum care within the community of residence, n (%) 1 0.28 .595 Yes 42 80.8 39 76.5 No 10 19.2 12 23.5 Delivery location (of most recent birth), n (%) 1 0.19 .663 At hospital 49 94.2 49 96.1 At home 3 5.8 2 3.9 PPD diagnosis by a health professional, n (%) 1 1.39 .238 Yes 11 21.2 16 31.4 No 41 78.8 35 68.6 PPA diagnosis by a health professional, n (%) 1 0.65 .422 Yes 11 21.2 14 28.0 No 41 78.8 36 72.0 cMedication use to treat mental health conditions such as PPD/PPA (i.e., SSRI, NDRI), n (%) 1 0.38 .540 Yes 15 28.8 12 23.5 No 37 71.2 39 76.5 Note: BC = British Columbia; CAD = Canadian Dollar; GED = General Educational Development; NDRI = Norepinephrine and Dopamine Reuptake Inhibitor; PPA = Postpartum Anxiety; PPD = Postpartum Depression; SSRI = Selective Serotonin Reuptake Inhibitor. aSome statistics (ethnicity, type of indigenous identity, and ages of children) are reported individually in questions that were ‘checkbox’ style, where participants could select all options that applied. bLocation of residence within BC was entered as a “fill in the blank” option on the Qualtrics demographic questionnaire. As such, it has been recoded as a categorical variable to calculate descriptive statistics. cMedication use was entered as a “fill in the blank” option on the Qualtrics demographic questionnaire. As such, it has been recoded as a dichotomous categorical variable to calculate descriptive statistics. 120 C.3 Pairwise Comparisons Table Table A3 Pairwise Comparisons for the Interaction Effect of Time of Assessment and Group on Postpartum Depression and Anxiety Scores Variable Group (I) Time (J) Time MD (I-J) SE p 95% CI for Differenceb Lower Bound Upper Bound PPD (EPDS) Waitlist Control T1 T2 0.62 0.63 .327 -0.63 1.88 T3 1.20 0.71 .096 -0.22 2.61 Intervention T1 T2 2.85* 0.65 <.001 1.57 4.14 T3 2.96* 0.73 <.001 1.52 4.41 PPA (PASS) Waitlist Control T1 T2 1.33 1.68 .430 -2.01 4.67 T3 2.66 1.83 .148 -0.97 6.29 Intervention T1 T2 7.42* 1.74 <.001 3.97 10.87 T3 8.07* 1.89 <.001 4.31 11.82 Note: Comparisons based on estimated marginal means. EPDS = Edinburgh Postnatal Depression Scale; PASS = Perinatal Anxiety Screening Scale; PPD = Postpartum Depression; PPA = Postpartum Anxiety. *Significant mean difference p < .001. bAdjustment for multiple comparisons using least significant difference (equivalent to no adjustments). 121 C.4 System Usability and Satisfaction Measures Table Table A4 Descriptive Statistics of Website Usability and Satisfaction Outcome Variables by Intervention Participants at T2 Outcome measure N M ± SD aPGIC 1: PPD/PPA symptom improvement 47 3.74 ± 0.94 bPGIC 2: Quality of life 47 3.06 ± 0.73 cPGIC 3: Overall website satisfaction 46 5.56 ± 2.05 dSUS 47 67.29 ± 21.15 ePEMAT Understandability 45 85.23 ± 20.63 ePEMAT Actionability 45 84.07 ± 23.56 fUPWQI Technical Adequacy 47 5.17 ± 1.04 fUPWQI Content Quality 47 5.27 ± 1.32 fUPWQI Specific Content 47 4.97 ± 1.15 fUPWQI Appearance 47 5.31 ± 1.40 Note: PGIC = Patient Global Impression of Change; PPA = Postpartum Anxiety; PPD = Postpartum Depression; SUS = System Usability Scale; PEMAT = Patient Education Materials Assessment Tool; UPWQI = User-Perceived Web Quality Instrument. aLikert scale range from 1 (complete recovery) to 6 (deterioration). bLikert scale range from 1 (great improvement) to 5 (deterioration). cScale range from 0 (completely dissatisfied) to 10 (completely satisfied). dTotal scores range from 0 to 100. eScores represent percentage for understandability or actionability. fScores range from 1 (completely disagree) to 7 (completely agree). 122 C.5 Website Metrics Table Table A5 Website Metrics of Intervention Participants by Website Section Website section Average page visits per participant Average time per session (minutes) Total page views Most visited outsources Education 1.06 48 56 → Perinatal Services BC: health professionals page → Perinatal Services BC: EPDS questionnaire Supports 0.93 37 49 → PsychCentral: self-care info blog → Pacific Postpartum Support Society: self-care questionnaire Resources 0.23 106 12 → Villageofmoms.com → Postpartumdads.org Mood/Anxiety Tracker 1.02 33 82 → PsychCentral: self-care tips blog Note: n = 47; BC = British Columbia; EPDS = Edinburgh Postnatal Depression Scale.
Thesis/Dissertation
eng
Women+ and Children’s Health Sciences
Vancouver : University of British Columbia Library
Attribution-NonCommercial-NoDerivatives 4.0 International
Graduate
Brotto, Lori A.
Breau, Genevieve Marie
Evaluating the effectiveness of a web-enabled psychoeducational intervention for postpartum mental health for women in British Columbia
Text