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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795652
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Distance Treatment for postpartum depression Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program
Study Start Date : May 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Distance Treatment
50% randomized to receive Distance Treatment for postpartum depression
 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 usual care services for postpartum depression


Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis with SCID (Semi-structured diagnostic interview) [ Time Frame: baseline, 120, 240, 365 ]

Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: baseline, 120, 240, 365 ]
  2. Sheehan Disability Scale [ Time Frame: Baseline, 120, 240, 365 ]
  3. Satisfaction measure, designed by the investigator [ Time Frame: end of intervention ]
  4. Beck Depression Inventory-II [ Time Frame: baseline, 120, 240 and 365 day follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795652


Locations
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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
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Principal Investigator: Patrick J McGrath, PhD IWK Health Centre
More Information
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Publications:

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Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00795652    
Other Study ID Numbers: 3556
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate summary data would be made available but not individual data.
Keywords provided by IWK Health Centre:
Postpartum depression
Distance therapy
depression
Distance Treatment
Barriers to care
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Puerperal Disorders
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases