A Phase 2 interventional study of Postpartumcare.ca (Web-Enabled Intervention) in Postpartum Depression, Postpartum Anxiety and Postnatal Depression, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of British Columbia · Phase 2, Interventional, and Treatment
The SUPPORT Study aims to evaluate the effectiveness and usability of postpartumcare.ca, a web-enabled resource for postpartum depression (PPD) and postpartum anxiety (PPA), created based on the input of birthing parents in British Columbia (BC) affected by these disorders.
This is Phase 3 of a multi-phase project that will be completed under the supervision of Dr. Lori Brotto, the University of British Columbia Sexual Health Lab and the Women's Health Research Institute at BC Women's Hospital.
The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca using three outcomes: (1) depression and anxiety; (2) system usability and satisfaction; and (3) website metrics. Parents aged 19 or older experiencing postpartum depression and/or anxiety living in BC who gave birth in the past 12 months will be eligible. Fifty will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned waitlist control, receiving treatment as usual.
Depression and anxiety symptoms will be measured at baseline, after the 4-week intervention period, and again 2 weeks later using the Edinburgh Postnatal Depression Scale (EPDS) and Perinatal Anxiety Screening Scale (PASS). After 4 weeks, system usability and satisfaction will be measured using the System Usability Scale (SUS), and website metrics will be collected for the intervention group only.
Multivariate analyses will be conducted to compare the anxiety and depression total scores and subscale scores between the two groups (intervention and treatment as usual). Descriptive analyses will be conducted on the satisfaction and usability questionnaires and website metrics.
The investigators hypothesize that following the use of postpartumcare.ca, the intervention group will see a greater reduction in depression and/or anxiety symptoms compared to the control group and that the website will be rated as usable.
The findings from this trial will add to the existing body of literature investigating the use of eHealth interventions for PPD and PPA treatment. Moreover, postpartumcare.ca will serve as a practical tool for birthing persons in BC in need of accessible and effective support.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's enrollment of 103 is close to the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Fifty participants will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for a period of 4 weeks. Intervention group participants may use postpartumcare.ca as often as desired for the duration of the 4-week intervention period. Following the 4-week intervention period and a 2-week follow-up period, intervention group participants will retain access to postpartumcare.ca.
Other: Postpartumcare.ca (Web-Enabled Intervention)
Fifty participants will be randomized to a waitlist control group, receiving treatment as usual (TAU) for a period of 4 weeks. Following the 4-week intervention period and a 2-week follow-up period, waitlist control participants will receive access to postpartumcare.ca.
Postpartumcare.ca is a web-enabled intervention accessible via computer, tablet or smartphone devices. The content and design of postpartumcare.ca were created based on the needs, opinions, and desires of birthing parents in British Columbia affected by postpartum depression and/or anxiety, which were solicited previously in phases 1 \& 2 of the SUPPORT study.
Change from Baseline Postpartum Depression at 4 weeks and 6 weeks, evaluated using the Edinburgh Postnatal Depression Scale (EPDS).
Changes in postpartum depression will be evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a standard scale used internationally to evaluate postpartum depression in the clinical setting and is recommended for screening of all postpartum parents who gave birth in British Columbia. Scoring on the EPDS ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
Time frame: The EPDS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Change from Baseline Postpartum Anxiety at 4 weeks and 6 weeks, evaluated using the Perinatal Anxiety Screening Scale (PASS).
Changes in postpartum anxiety will be evaluated using the Perinatal Anxiety Screening Scale (PASS). The PASS is a commonly used measure for screening for anxiety in the perinatal period. Scoring on the PASS ranges from 0 to 93, with higher scores indicating more severe anxiety symptoms
Time frame: The PASS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Website usability, as evaluated using the System Usability Scale (SUS)
Usability of the website intervention will be measured using a modified version of the System Usability Scale (SUS). The SUS is a reliable tool for measuring usability consisting of a 10-item questionnaire with 5 response options ranging from Strongly Agree to Strongly Disagree.
Time frame: Website usability will be evaluated after the 4-week intervention period for the intervention group only
Website satisfaction, evaluated using the Patient Global Impression of Change (PGIC) questionnaire
Satisfaction with the website intervention will be measured using a brief Patient Global Impression of Change (PGIC) questionnaire developed for this study. the PGIC describes a participant's belief about the efficacy of treatment on a 7 point scale where change is rated as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse.".
Time frame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Website satisfaction, evaluated using the user-perceived web quality instrument
Satisfaction with the website intervention will be measured using the user-perceived web quality instrument. The user perceived web quality instrument is a 25-item instrument that measures four dimensions of web quality: specific content, content quality, appearance and technical adequacy.
Time frame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Website satisfaction, evaluated using the Patient Education Materials Assessment Tool (PEMAT)
Satisfaction with the website intervention will be measured using the Patient Materials Assessment Tool (PEMAT). The PEMAT evaluates and compares the understandability and actionability of patient education materials using a 26-item scale.
Time frame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Website metrics including average time on page, average session duration, returning visitors, and number of pages visited per session.
Website metrics describe how participants use the website intervention. Included website metrics will be average time on page, average session duration, returning visitors, and the number of pages visited per session. These metrics will be collected using Matomo Analytics.
Time frame: Website metrics will be collected after the 4-week intervention period for the intervention group only
Plan to share: No
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Ran from Apr 2022 to primary completion in Apr 2023, 11 months.
Of 14 phase 2 interventional studies under Depression, Postpartum, half reached primary completion within 17 months of starting (the median); a quarter within 10 and three quarters within 30. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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