Mother Matters Online Postpartum Support

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Mother Matters Online Postpartum Support Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Condition (ITC)<br>Mother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization. | Behavioral: Mother Matters Online Postpartum Support Group<br>* 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.<br>|
| No Intervention: Waitlist Control Condition (WLC)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Feasibility (Eligibility) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Proportion of participants who complete follow-up measures | Follow-up (about 10 weeks post-randomization) | 
| Recruitment Feasibility (Recruitment) | The number of women recruited to the study | One year from when the study starts enrolling participants | 
| Trial Protocol Adherence (Weekly Posting) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pilot RCT, waitlist-controlled RCT, postpartum depression