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Clinical Trials/NCT02953626
NCT02953626
Completed
Not Applicable

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

Women's College Hospital1 site in 1 country96 target enrollmentMay 2016
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Women's College Hospital
Enrollment
96
Locations
1
Primary Endpoint
Recruitment Feasibility (Eligibility)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Edinburgh Postnatal Depressive Scale (EPDS)(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)(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)(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)(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)(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)(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)(Follow-up (about 10 weeks post-randomization))
  • Recruitment Feasibility (Recruitment)(One year from when the study starts enrolling participants)
  • Trial Protocol Adherence (Weekly Posting)(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)(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))

Study Sites (1)

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