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Completed

NCT Number: NCT02953626

Mother Matters Online Postpartum Support

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Research Institute

Toronto, Ontario, M5S 1B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mother Matters Online Postpartum Support Group

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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