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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Distance Treatment for postpartum depression
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum depression, Distance therapy, depression, Distance Treatment, Barriers to care

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Distance Treatment

Usual Care Services

Arm Description

50% randomized to receive Distance Treatment for postpartum depression

50% randomized to receive usual care services for postpartum depression

Outcomes

Primary Outcome Measures

Diagnosis with SCID (Semi-structured diagnostic interview)

Secondary Outcome Measures

Edinburgh Postnatal Depression Scale
Sheehan Disability Scale
Satisfaction measure, designed by the investigator
Beck Depression Inventory-II

Full Information

First Posted
November 19, 2008
Last Updated
September 1, 2016
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00795652
Brief Title
Mom: Managing Our Mood, Part of The Family Help Program
Acronym
MOM
Official Title
Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum depression, Distance therapy, depression, Distance Treatment, Barriers to care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distance Treatment
Arm Type
Experimental
Arm Description
50% randomized to receive Distance Treatment for postpartum depression
Arm Title
Usual Care Services
Arm Type
No Intervention
Arm Description
50% randomized to receive usual care services for postpartum depression
Intervention Type
Behavioral
Intervention Name(s)
Distance Treatment for postpartum depression
Other Intervention Name(s)
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
Intervention Description
Evidence-based, cognitive behavioural intervention for women with postpartum depression
Primary Outcome Measure Information:
Title
Diagnosis with SCID (Semi-structured diagnostic interview)
Time Frame
baseline, 120, 240, 365
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Time Frame
baseline, 120, 240, 365
Title
Sheehan Disability Scale
Time Frame
Baseline, 120, 240, 365
Title
Satisfaction measure, designed by the investigator
Time Frame
end of intervention
Title
Beck Depression Inventory-II
Time Frame
baseline, 120, 240 and 365 day follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J McGrath, PhD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate summary data would be made available but not individual data.
Citations:
PubMed Identifier
18632994
Citation
Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
Results Reference
background
PubMed Identifier
18025870
Citation
Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
Results Reference
background
PubMed Identifier
17227604
Citation
Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
Results Reference
background
PubMed Identifier
19270846
Citation
McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
Results Reference
background
PubMed Identifier
18632997
Citation
Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
Results Reference
background

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

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