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Mother Matters Online Postpartum Support

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mother Matters Online Postpartum Support Group
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring pilot RCT, waitlist-controlled RCT, postpartum depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Women's College Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Treatment Condition (ITC)

Waitlist Control Condition (WLC)

Arm Description

Mother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization.

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.

Outcomes

Primary Outcome Measures

Recruitment Feasibility (Eligibility)
The proportion of participants eligible to participate in Mother Matters

Secondary Outcome Measures

Edinburgh Postnatal Depressive Scale (EPDS)
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.
State-Trait Anxiety Inventory (STAI)
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.
The Change in Eating Disorder Symptoms Scale (CHEDS)
The investigators will measure eating disorder symptoms use the CHEDS, which is designed to assess change in eating disorder symptoms and their severity.
Parenting Stress Index, Short Form (PSI)
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.
Intervention Acceptability (Qualitative)
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.
Intervention Acceptability (Website Usage)
Proportion of intervention weeks that participant logs in to the forum
Trial Protocol Adherence (Study Measure Completion)
Proportion of participants who complete follow-up measures
Recruitment Feasibility (Recruitment)
The number of women recruited to the study
Trial Protocol Adherence (Weekly Posting)
The number of participants who post in the forum at least on a weekly basis
Trial Protocol Adherence (Posting Drop-Off)
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)

Full Information

First Posted
June 13, 2016
Last Updated
May 11, 2017
Sponsor
Women's College Hospital
Collaborators
Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02953626
Brief Title
Mother Matters Online Postpartum Support
Official Title
Mother Matters: Pilot Randomized Waitlist Controlled Trial of an Online Postpartum Mental Health Support Group
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre, University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
pilot RCT, waitlist-controlled RCT, postpartum depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment Condition (ITC)
Arm Type
Experimental
Arm Description
Mother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization.
Arm Title
Waitlist Control Condition (WLC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mother Matters Online Postpartum Support Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Feasibility (Eligibility)
Description
The proportion of participants eligible to participate in Mother Matters
Time Frame
One year from when the study starts enrolling participants
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depressive Scale (EPDS)
Description
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.
Time Frame
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Title
The Change in Eating Disorder Symptoms Scale (CHEDS)
Description
The investigators will measure eating disorder symptoms use the CHEDS, which is designed to assess change in eating disorder symptoms and their severity.
Time Frame
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Title
Parenting Stress Index, Short Form (PSI)
Description
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.
Time Frame
Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Title
Intervention Acceptability (Qualitative)
Description
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.
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)
Title
Intervention Acceptability (Website Usage)
Description
Proportion of intervention weeks that participant logs in to the forum
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)
Title
Trial Protocol Adherence (Study Measure Completion)
Description
Proportion of participants who complete follow-up measures
Time Frame
Follow-up (about 10 weeks post-randomization)
Title
Recruitment Feasibility (Recruitment)
Description
The number of women recruited to the study
Time Frame
One year from when the study starts enrolling participants
Title
Trial Protocol Adherence (Weekly Posting)
Description
The number of participants who post in the forum at least on a weekly basis
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)
Title
Trial Protocol Adherence (Posting Drop-Off)
Description
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)
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria The specific inclusion criteria for this group are women who are: Mothers of a baby/babies between 0 and 12 months old at enrollment, and Over 18 years old, and Have an Edinburgh Postnatal Depression Scale (EPDS) score of >9, and Reside in Ontario. Exclusion Criteria Women will not be eligible to participate in the study if they are: Experiencing active suicidal ideation, or Have active substance use, mania or psychosis, or Unable to access the internet, or Unable to participate in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Vigod, MD,MSc,FRCPC
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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