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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
  Purpose

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).


Condition Intervention
Postnatal Depression
 Behavioral: CBT-Counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Melbourne:

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

Enrollment: 68
Study Start Date: November 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBT-counselling with Nurse
CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner
 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).
Active Comparator: CBT-Counselling by Psychologist
CBT-counselling with Psychologist, adjunctive to management by general medical practitioner
 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).
No Intervention: Routine management
Ongoing management by general medical practitioner

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking women at 3-months postpartum

Exclusion Criteria:

  • Psychosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002027

Locations
Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3081
Sponsors and Collaborators
University of Melbourne
Beyondblue (The National Depression Initiative)
Investigators
Principal Investigator: Jeannette Milgrom, PhD University of Melbourne & Austin Health
  More Information

No publications provided by University of Melbourne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeannette Milgrom, University of Melbourne & Austin Health
ClinicalTrials.gov Identifier: NCT01002027     History of Changes
Other Study ID Numbers: H2005/01895
Study First Received: October 23, 2009
Last Updated: October 26, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Melbourne:
Postnatal Depression
CBT-Counselling
Primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013