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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Postpartum Depression Postpartum Anxiety Postnatal Depression Perinatal Disorder Perinatal Depression Postpartum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Postpartumcare.ca (Web-Enabled Intervention)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Women's Health Research Institute of British Columbia

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Lori Brotto

Director, UBC Sexual Health Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women's Heath Research Institute

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

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.

Reference Type DERIVED
PMID: 38709329 (View on PubMed)

Other Identifiers

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H21-03407

Identifier Type: -

Identifier Source: org_study_id

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