Mother Matters Online Postpartum Support

May 11, 2017 updated by: Women's College Hospital

Mother Matters: Pilot Randomized Waitlist Controlled Trial of an Online Postpartum Mental Health Support Group

Postpartum depression is common, yet only 20% of women seek treatment. Online support groups are a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online psychotherapy group for women with postpartum depression & anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of proceeding to a large-scale RCT evaluation of the Mother Matters intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The postpartum period is a particularly vulnerable time for the development of mental health concerns; postpartum depression (i.e. depression with onset between 0-12 months postpartum) affects approximately 13% of mothers in Canada. There are serious negative consequences to both mother and child during this period, yet only 20% of women seek treatment, citing significant systematic and personal barriers. Online support groups have been identified as a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online support group for women with postpartum depression and anxiety, run trained psychotherapists in the Reproductive Life Stages (RLS) program at Women's College Hospital in Toronto, Ontario. Mother Matters was designed to address barriers related to accessing postpartum mental health services: it can be accessed anywhere (online group), at any time (available 24/7), and with anonymity (to address the barrier of shame/stigma). The overall objective of the current pilot RCT is to determine the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the group, comparing outcomes among those with and without access to the program.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Women's College Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

The specific inclusion criteria for this group are women who are:

  1. Mothers of a baby/babies between 0 and 12 months old at enrollment, and
  2. Over 18 years old, and
  3. Have an Edinburgh Postnatal Depression Scale (EPDS) score of >9, and
  4. Reside in Ontario.

Exclusion Criteria

Women will not be eligible to participate in the study if they are:

  1. Experiencing active suicidal ideation, or
  2. Have active substance use, mania or psychosis, or
  3. Unable to access the internet, or
  4. Unable to participate in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Treatment Condition (ITC)
Mother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization.
Behavioral: Mother Matters Online Postpartum Support Group
Mother Matters is a 10-week online support group for women with postpartum depression. It involves: 1) A private, online forum that can be accessed by participants 24-hours per day. During regular business hours (9:00 am to 5:00 pm on weekdays) it is moderated by a psychotherapist, and there is a weekly moderated "live" chat hour; 2) Weekly topics with readings are provided with questions to prompt discussion on the online forum. Topics incorporate symptom management (i.e. Interpersonal Therapy, Cognitive Behavioural Therapy) and affect regulation strategies (i.e. Mindfulness, DBT) with a supportive counselling approach. External resources related to each week's topic, are also shared.
No Intervention: Waitlist Control Condition (WLC)
Mother Matters Online Postpartum Support Group. Participants will receive the intervention after the Immediate Treatment Condition group completes the intervention, and after follow-up data are collected from both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Feasibility (Eligibility)
Time Frame: One year from when the study starts enrolling participants
The proportion of participants eligible to participate in Mother Matters
One year from when the study starts enrolling participants

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depressive Scale (EPDS)
Time Frame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
The investigators will measure depressive symptoms using the EPDS, a self-report depression screening measure that has been validated for use in pregnancy. EPDS scores >12 are predictive of a diagnosis of major depressive disorder.
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
State-Trait Anxiety Inventory (STAI)
Time Frame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
The investigators will measure anxious symptoms using the STAI, a self-report anxiety screening measure that has shown good discriminate validity in perinatal populations. STAI scores >48 are predictive of having an anxiety disorder diagnosis.
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
The Change in Eating Disorder Symptoms Scale (CHEDS)
Time Frame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
The investigators will measure eating disorder symptoms use the CHEDS, which is designed to assess change in eating disorder symptoms and their severity.
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Parenting Stress Index, Short Form (PSI)
Time Frame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
The investigators will measure stress in the parent-child relationship using the PSI short form, a 36-item measure which consists of three sub-scales.
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Intervention Acceptability (Qualitative)
Time Frame: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
Mother Matters Program Evaluation Questionnaire. This is comprised of open- and closed-ended questions to elicit feedback on a) content, clarity and helpfulness of the group, b) acceptability of the group format, c) satisfaction with the group, including reasons for discontinuation, d) the facilitators availability and helpfulness, and e) whether or not participants would recommend it to other women experiencing depressive symptoms in the first postpartum year.
Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
Intervention Acceptability (Website Usage)
Time Frame: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
Proportion of intervention weeks that participant logs in to the forum
Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
Trial Protocol Adherence (Study Measure Completion)
Time Frame: Follow-up (about 10 weeks post-randomization)
Proportion of participants who complete follow-up measures
Follow-up (about 10 weeks post-randomization)
Recruitment Feasibility (Recruitment)
Time Frame: One year from when the study starts enrolling participants
The number of women recruited to the study
One year from when the study starts enrolling participants
Trial Protocol Adherence (Weekly Posting)
Time Frame: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
The number of participants who post in the forum at least on a weekly basis
Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
Trial Protocol Adherence (Posting Drop-Off)
Time Frame: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)
The drop-off rate for postings (i.e. the number of participants who post in the initial weeks but not in the latter half of the group)
Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

Sunnybrook Health Sciences Centre
Centre for Addiction and Mental Health
University of Toronto

Investigators

  • Principal Investigator: Simone Vigod, MD,MSc,FRCPC, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0032-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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