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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01002027
Other study ID # H2005/01895
Secondary ID
Status Completed
Phase N/A
First received October 23, 2009
Last updated October 26, 2009
Start date November 2004
Est. completion date February 2007

Study information

Verified date October 2009
Source University of Melbourne
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- English-speaking women at 3-months postpartum

Exclusion Criteria:

- Psychosis

Study Design

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


Intervention

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).

Locations

Country Name City State
Australia Austin Health Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
University of Melbourne Beyondblue (The National Depression Initiative)

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Depression Score 8 weeks post-randomization No
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