- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795652
Mom: Managing Our Mood, Part of The Family Help Program (MOM)
Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Distance Treatment
50% randomized to receive Distance Treatment for postpartum depression
|
Evidence-based, cognitive behavioural intervention for women with postpartum depression
Other Names:
|
No Intervention: Usual Care Services
50% randomized to receive usual care services for postpartum depression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnosis with SCID (Semi-structured diagnostic interview)
Time Frame: baseline, 120, 240, 365
|
baseline, 120, 240, 365
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Edinburgh Postnatal Depression Scale
Time Frame: baseline, 120, 240, 365
|
baseline, 120, 240, 365
|
Sheehan Disability Scale
Time Frame: Baseline, 120, 240, 365
|
Baseline, 120, 240, 365
|
Satisfaction measure, designed by the investigator
Time Frame: end of intervention
|
end of intervention
|
Beck Depression Inventory-II
Time Frame: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick J McGrath, PhD, IWK Health Centre
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on Distance Treatment for postpartum depression
-
University of PittsburghNational Institute of Mental Health (NIMH)Completed
-
Henry Ford Health SystemNational Institute of Mental Health (NIMH); University of Colorado, BoulderNot yet recruitingPostpartum Depression
-
Hospital Universitario Dr. Jose E. GonzalezUnknown
-
US Department of Veterans AffairsCompletedSubstance-Related Disorders | Mood DisordersUnited States
-
University of North Carolina, Chapel HillCompleted
-
California Polytechnic State University-San Luis...University of North Carolina, Chapel HillCompleted
-
University of Maryland, College ParkCompletedDepressionUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingPostpartum Depression | Postpartum AnxietyUnited States
-
Boston University Charles River CampusMassachusetts Institute of TechnologyNot yet recruitingChildhood DepressionUnited States
-
Lovisenberg Diakonale HospitalOslo Metropolitan UniversityCompleted