The SUPPORT Study: Effectiveness and Usability of a Web-Enabled Resource for Postpartum Mental Health

Postpartum Depression Clinical Trial

— SUPPORT  

Official title:

The SUPPORT Study: Survey and Development of a Universally Accessible Postpartum Online Resource for the Treatment of Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05382884
• Other study ID #: H21-03407
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• have given birth within the past 12 months

• 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:

• have not given birth within the past 12 months

• 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Disease
• Perinatal Depression
• Perinatal Disorder
• Postnatal Depression
• Postpartum Anxiety
• Postpartum Depression
• Postpartum Disorder
• Puerperal Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Women's Heath Research Institute	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Women's Health Research Institute of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The EPDS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Primary	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	The PASS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Primary	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.	Website usability will be evaluated after the 4-week intervention period for the intervention group only
Primary	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.".	Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Primary	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.	Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Primary	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.	Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Primary	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.	Website metrics will be collected after the 4-week intervention period for the intervention group only