Clinical trial NCT05382884: The SUPPORT Study: Effectiveness and Usability of a Web-Enabled Resource for Postpartum Mental Health
Official title: The SUPPORT Study: Survey and Development of a Universally Accessible Postpartum Online Resource for the Treatment of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Depression
Postpartum Anxiety
Postnatal Depression
Perinatal Disorder
Perinatal Depression
Postpartum Disorder
Keywords: Postpartum Depression
Postpartum Anxiety
Perinatal
Postnatal
eHealth
Online Intervention
Website
Web-Enabled
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Women's Health Research Institute of British Columbia
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-05-19
Enrollment: 103
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca. Fifty participants will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned to a waitlist control group, receiving treatment as usual for the duration of the 4-week intervention period. Following the 4-week intervention period and 2-week follow-up, participants from both groups will be able to access postpartumcare.ca.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Postpartum Depression at 4 weeks and 6 weeks, evaluated using the Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: The EPDS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
measure: Change from Baseline Postpartum Anxiety at 4 weeks and 6 weeks, evaluated using the Perinatal Anxiety Screening Scale (PASS).
timeFrame: The PASS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
measure: Website usability, as evaluated using the System Usability Scale (SUS)
timeFrame: Website usability will be evaluated after the 4-week intervention period for the intervention group only
measure: Website satisfaction, evaluated using the Patient Global Impression of Change (PGIC) questionnaire
timeFrame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
measure: Website satisfaction, evaluated using the user-perceived web quality instrument
timeFrame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
measure: Website satisfaction, evaluated using the Patient Education Materials Assessment Tool (PEMAT)
timeFrame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
measure: Website metrics including average time on page, average session duration, returning visitors, and number of pages visited per session.
timeFrame: Website metrics will be collected after the 4-week intervention period for the intervention group only
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Women's Heath Research Institute
state: British Columbia
Study officials:
References: