Three Model Care Pathways for Postnatal Depression

This study has been completed.

Sponsor:

Collaborator:

Beyondblue (The National Depression Initiative)

Information provided by:

University of Melbourne

ClinicalTrials.gov Identifier:

NCT01002027

First received: October 23, 2009

Last updated: October 26, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 23, 2009

Last Updated Date

October 26, 2009

Start Date ^ICMJE

November 2004

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical Depression Score [ Time Frame: 8 weeks post-randomization ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01002027 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Three Model Care Pathways for Postnatal Depression

Official Title ^ICMJE

Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)

Brief Summary

The study evaluates three best-practice care pathways for postnatal depression (PND) by comparing sole General Practitioner (GP) management to GP management in combination with CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postnatal Depression

Intervention ^ICMJE

Behavioral: CBT-Counselling

Intervention entailed six sessions of counselling-CBT delivered either by a trained Nurse, or by a Psychologist. Sessions focussed on: psycho-education about PND, main issues of concern, assessment of symptom severity, problem solving. Behavioural interventions (pleasant activities, anxiety management, relaxation, relationship communication) were used together with cognitive interventions (understanding links between thoughts and feelings, increasing positive thoughts, challenging negative self-talk and unhelpful beliefs).

Study Arm (s)

Active Comparator: CBT-counselling with Nurse
CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner

Intervention: Behavioral: CBT-Counselling
Active Comparator: CBT-Counselling by Psychologist
CBT-counselling with Psychologist, adjunctive to management by general medical practitioner

Intervention: Behavioral: CBT-Counselling
No Intervention: Routine management
Ongoing management by general medical practitioner

Publications *

Milgrom J, Holt CJ, Gemmill AW, Ericksen J, Leigh B, Buist A, Schembri C. Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling. BMC Psychiatry. 2011 May 27;11:95.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

English-speaking women at 3-months postpartum

Exclusion Criteria:

Psychosis

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT01002027

Other Study ID Numbers ^ICMJE

H2005/01895

Has Data Monitoring Committee

Responsible Party

Jeannette Milgrom, University of Melbourne & Austin Health

Study Sponsor ^ICMJE

University of Melbourne

Collaborators ^ICMJE

Beyondblue (The National Depression Initiative)

Investigators ^ICMJE

Principal Investigator:

Jeannette Milgrom, PhD

University of Melbourne & Austin Health

Information Provided By

University of Melbourne

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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