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Three Model Care Pathways for Postnatal Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002027
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beyondblue (The National Depression Initiative)
Information provided by:
University of Melbourne
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Clinical Depression Score [ Time Frame: 8 weeks post-randomization ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking women at 3-months postpartum

Exclusion Criteria:

  • Psychosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 23, 2009
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
Last Verified: October 2009

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