search
Back to results

Three Model Care Pathways for Postnatal Depression

Primary Purpose

Postnatal Depression

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CBT-Counselling
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression focused on measuring Postnatal Depression, CBT-Counselling, Primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • English-speaking women at 3-months postpartum

Exclusion Criteria:

  • Psychosis

Sites / Locations

  • Austin Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

CBT-counselling with Nurse

CBT-Counselling by Psychologist

Routine management

Arm Description

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

CBT-counselling with Psychologist, adjunctive to management by general medical practitioner

Ongoing management by general medical practitioner

Outcomes

Primary Outcome Measures

Clinical Depression Score

Secondary Outcome Measures

Full Information

First Posted
October 23, 2009
Last Updated
October 26, 2009
Sponsor
University of Melbourne
Collaborators
Beyondblue (The National Depression Initiative)
search

1. Study Identification

Unique Protocol Identification Number
NCT01002027
Brief Title
Three Model Care Pathways for Postnatal Depression
Official Title
Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Melbourne
Collaborators
Beyondblue (The National Depression Initiative)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
Postnatal Depression, CBT-Counselling, Primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-counselling with Nurse
Arm Type
Active Comparator
Arm Description
CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner
Arm Title
CBT-Counselling by Psychologist
Arm Type
Active Comparator
Arm Description
CBT-counselling with Psychologist, adjunctive to management by general medical practitioner
Arm Title
Routine management
Arm Type
No Intervention
Arm Description
Ongoing management by general medical practitioner
Intervention Type
Behavioral
Intervention Name(s)
CBT-Counselling
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinical Depression Score
Time Frame
8 weeks post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English-speaking women at 3-months postpartum Exclusion Criteria: Psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette Milgrom, PhD
Organizational Affiliation
University of Melbourne & Austin Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21615968
Citation
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. doi: 10.1186/1471-244X-11-95.
Results Reference
derived

Learn more about this trial

Three Model Care Pathways for Postnatal Depression

We'll reach out to this number within 24 hrs