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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00795652
First received: November 19, 2008
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Postpartum Depression
Behavioral: Distance Treatment for postpartum depression
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Diagnosis with SCID (Semi-structured diagnostic interview) [ Time Frame: baseline, 120, 240, 365 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Edinburgh Postnatal Depression Scale [ Time Frame: baseline, 120, 240, 365 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Baseline, 120, 240, 365 ] [ Designated as safety issue: No ]
  • Satisfaction measure, designed by the investigator [ Time Frame: end of intervention ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Distance Treatment
50% randomized to receive Mom:Managing our Mood intervention
Behavioral: Distance Treatment for postpartum depression
Evidence-based, cognitive behavioural intervention for women with postpartum depression
Other Names:
  • Family Help Program (listed below: other Modules registered)
  • Pediatric Anxiety (2234a) NCT00267566
  • Pediatric Disruptive Behaviour (2234b) NCT00267579
  • Pediatric ADHD NCT00267605
  • Pediatric Recurrent Headache/abdominal Pain NCT00267618
  • Pediatric Enuresis NCT00270621
  • Pediatric Sleep Disorder NCT00338429
No Intervention: Usual Care Services
50% randomized to receive standard/usual care for postpartum depression

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795652

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J McGrath, PhD IWK Health Centre
  More Information

Publications:
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00795652     History of Changes
Other Study ID Numbers: 3556
Study First Received: November 19, 2008
Last Updated: October 2, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by IWK Health Centre:
Postpartum depression
Distance therapy
depression

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders

ClinicalTrials.gov processed this record on November 24, 2014