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

NCT05382884 | Completed Phase 2

• 1 other identifier: H21-03407
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Waitlist Control

NO 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.

Interventions

Postpartumcare.ca (Web-Enabled Intervention) OTHER

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.

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Women's Health Research Institute of British Columbia: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Women's Heath Research Institute

Vancouver, British Columbia, V6H 2N9, Canada

Location

Related Publications (1)

• 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.

  PMID: 38709329 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UBC Sexual Health Laboratory

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: April 20, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)