Mom: Managing Our Mood, Part of The Family Help Program

Study Overview
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Brief Summary
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The purpose of the MOM: Managing Our Mood Program (part of Family Help) is to evaluate the effectiveness of the Family Help distance intervention compared to usual or standard care typically provided to women with mild to moderate postpartum depression symptomology. This is a single-center trial based at the IWK Health Center. The primary outcome is change in postpartum depression diagnosis.

Detailed Description
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The Family Help- MOM: Managing Our Mood Program is to deliver, primary care mental health services to mothers in the comfort and privacy of their own home. The purpose of this randomized control trial is to test the effectiveness of the Managing Our Mood (MOM) postpartum depression distance treatment program. This study is a single-centre trial based at the IWK Health Centre, similar to other Family Help Modules. The goal of this study is to determine the effectiveness of the MOM cognitive-behavioural intervention as an alternative treatment for women suffering from postpartum depression. The intervention is delivered at a distance, using educational materials (handbooks, video-tapes/DVDs, and telephone consultation with a trained paraprofessional coach. Family Help coaches deliver consistent care based on written protocols, with on-going evaluation by a professional team. MOM is not designed to replace specialist care of complex multi-problem mothers. Eligible participants will be randomly assigned to either active MOM treatment or to the Best Efforts control condition. Those participants assigned to Best Efforts receive printed information about postpartum depression that describes the illness, how it is caused and various treatment options; they are assigned a Coach who books their assessments and is available to answer any questions; they are encouraged to maintain contact and regular care with their family physician or public health nurse for both themselves and their baby. At the end of the 12-month follow-up (one year from randomization), these women will be offered the opportunity to take part in the MOM treatment if they are still depressed.

Official Title
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Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Distance Treatment for postpartum depression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed diagnostic measure (SCID), reviewed and signed off by a psychologist Participant must meet DSM-IV criteria for postpartum depression Significant depressive symptoms that have been present for at least 2 weeks Participant must be within 1-12 months postpartum Participant must have ready private access to a telephone Participant must be between 19-45 years old Participant has provided verbal telephone consent Participants must speak, read and write in English If they are taking medication they must be stabilized (have been on the medication for at least four weeks). Exclusion Criteria: Any condition that in the judgment of the psychologist may interfere with effective delivery of the treatment program (ie, Severe symptomology, challenging diagnostic dilemmas, families who are unmotivated or are in complete chaos) Current reports of specific suicidal intentions Actively suicidal; suicidal attempts in the previous 6 months Participants who are not willing to commit to the demands of treatment Participants who have had psychological treatment in the past 6 months for similar problems. Participants who have a history of psychotic disorders Participants who are cognitively impaired Participants who are involved with child protection services Participants who have significant substance dependency

Ages Eligible for Study
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Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distance Treatment<br>50% randomized to receive Distance Treatment for postpartum depression | Behavioral: Distance Treatment for postpartum depression<br>* Evidence-based, cognitive behavioural intervention for women with postpartum depression<br>* Other names: Pediatric Sleep Disorder NCT00338429;|
| No Intervention: Usual Care Services<br>50% randomized to receive usual care services for postpartum depression | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis with SCID (Semi-structured diagnostic interview) |  | baseline, 120, 240, 365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale |  | baseline, 120, 240, 365 | 
| Sheehan Disability Scale |  | Baseline, 120, 240, 365 | 
| Satisfaction measure, designed by the investigator |  | end of intervention | 
| Beck Depression Inventory-II |  | baseline, 120, 240 and 365 day follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum depression, Distance therapy, depression, Distance Treatment, Barriers to care