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Mother Matters Online Postpartum Support

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ClinicalTrials.gov Identifier: NCT02953626
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : May 12, 2017
Sponsor:
Collaborators:
Centre for Addiction and Mental Health
Sunnybrook Health Sciences Centre
University of Toronto
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Mother Matters Online Postpartum Support Group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mother Matters: Pilot Randomized Waitlist Controlled Trial of an Online Postpartum Mental Health Support Group
Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

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.



Primary Outcome Measures :
  1. Recruitment Feasibility (Eligibility) [ Time Frame: One year from when the study starts enrolling participants ]
    The proportion of participants eligible to participate in Mother Matters


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. Trial Protocol Adherence (Study Measure Completion) [ Time Frame: Follow-up (about 10 weeks post-randomization) ]
    Proportion of participants who complete follow-up measures

  8. Recruitment Feasibility (Recruitment) [ Time Frame: One year from when the study starts enrolling participants ]
    The number of women recruited to the study

  9. 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

  10. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953626


Locations
Canada, Ontario
Women's College Research Institute
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
Centre for Addiction and Mental Health
Sunnybrook Health Sciences Centre
University of Toronto
Investigators
Principal Investigator: Simone Vigod, MD,MSc,FRCPC Women's College Hospital

Publications:
Roberta Anniverno, A.B., Claudio Mencacci and Federico Durbano, Anxiety Disorders in Pregnancy and the Postpartum Period, in New Insights into Anxiety Disorders, D.F. Durbano, Editor. 2013.

Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02953626     History of Changes
Other Study ID Numbers: 2016-0032-B
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Women's College Hospital:
pilot RCT
waitlist-controlled RCT
postpartum depression

Additional relevant MeSH terms:
Depression
Behavioral Symptoms