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

NCT00795652 | Completed Phase 2

• 1 other identifier: 3556
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

Postpartum depression; Distance therapy; depression; Distance Treatment; Barriers to care

Outcome Measures

Primary Outcomes (1)

• Diagnosis with SCID (Semi-structured diagnostic interview)

  baseline, 120, 240, 365

Secondary Outcomes (4)

• Edinburgh Postnatal Depression Scale

  baseline, 120, 240, 365

• Sheehan Disability Scale

  Baseline, 120, 240, 365

• Satisfaction measure, designed by the investigator

  end of intervention

• Beck Depression Inventory-II

  baseline, 120, 240 and 365 day follow-up

Study Arms (2)

Distance Treatment

EXPERIMENTAL

50% randomized to receive Distance Treatment for postpartum depression

Behavioral: Distance Treatment for postpartum depression

Usual Care Services

NO INTERVENTION

50% randomized to receive usual care services for postpartum depression

Interventions

Distance Treatment for postpartum depression BEHAVIORAL

Evidence-based, cognitive behavioural intervention for women with postpartum depression

Also known as: 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

Distance Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (5)

• 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.

  PMID: 18632994 BACKGROUND

• 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.

  PMID: 18025870 BACKGROUND

• 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.

  PMID: 17227604 BACKGROUND

• 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.

  PMID: 19270846 BACKGROUND

• 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.

  PMID: 18632997 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Patrick J McGrath, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 21, 2008
• Study Start: May 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)