The SUPPORT Study: Effectiveness and Usability of a Web-Enabled Resource for Postpartum Mental Health
NCT ID: NCT05382884
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2022-04-20
2023-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
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.
Postpartumcare.ca (Web-Enabled Intervention)
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.
Waitlist Control
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.
No interventions assigned to this group
Interventions
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Postpartumcare.ca (Web-Enabled Intervention)
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.
Eligibility Criteria
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Inclusion Criteria
* reside in British Columbia
* be at least 19 years of age
* have the ability to communicate in English
* have a suspected diagnosis or symptoms of postpartum depression and/or anxiety, as measured by the Edinburgh Depression Scale, having a score of 9 or greater and/or PASS score of 26 or greater, as measured as part of the initial eligibility questionnaire
* have access to study materials online, that is, have internet access and a device to access the internet, such as a computer or smartphone
Exclusion Criteria
* reside outside of British Columbia
* under 19 years of age
* unable to communicate in English
* do not have a suspected diagnosis or symptoms of postpartum depression and/or anxiety, as measured by the Edinburgh Depression Scale, having a score of 8 or less and/or PASS score of 25 or less, as measured as part of the initial eligibility questionnaire
* do not have any internet access
19 Years
ALL
No
Sponsors
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Women's Health Research Institute of British Columbia
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of British Columbia
OTHER
Responsible Party
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Lori Brotto
Director, UBC Sexual Health Laboratory
Locations
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Women's Heath Research Institute
Vancouver, British Columbia, Canada
Countries
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References
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Lawrence CG, Breau G, Yang L, Hellerstein OS, Hippman C, Kennedy AL, Ryan D, Shulman B, Brotto LA. Effectiveness of a web-enabled psychoeducational resource for postpartum depression and anxiety among women in British Columbia. Arch Womens Ment Health. 2024 Dec;27(6):995-1010. doi: 10.1007/s00737-024-01468-8. Epub 2024 May 6.
Other Identifiers
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H21-03407
Identifier Type: -
Identifier Source: org_study_id
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