- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002027
Three Model Care Pathways for Postnatal Depression
October 26, 2009 updated by: University of Melbourne
Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3081
- Austin Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- English-speaking women at 3-months postpartum
Exclusion Criteria:
- Psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CBT-counselling with Nurse
CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Depression Score
Time Frame: 8 weeks post-randomization
|
8 weeks post-randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeannette Milgrom, PhD, University of Melbourne & Austin Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
October 23, 2009
First Submitted That Met QC Criteria
October 26, 2009
First Posted (Estimate)
October 27, 2009
Study Record Updates
Last Update Posted (Estimate)
October 27, 2009
Last Update Submitted That Met QC Criteria
October 26, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2005/01895
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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The University of Hong KongUnknown
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The Hong Kong Polytechnic UniversityCompletedPostnatal DepressionHong Kong
-
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-
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