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

Phase 2

Completed

• Conditions: Postpartum Depression
• Interventions: Behavioral: Distance Treatment for postpartum depression

• Registration Number: NCT00795652
• Lead Sponsor: IWK Health Centre

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distance Treatment	Distance Treatment for postpartum depression	50% randomized to receive Distance Treatment for postpartum depression

Primary Outcome Measures

Name	Time	Method
Diagnosis with SCID (Semi-structured diagnostic interview)	baseline, 120, 240, 365

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada