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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00663078
Other study ID # 07/H0107/60
Secondary ID
Status Completed
Phase Phase 0
First received April 18, 2008
Last updated January 13, 2010
Start date August 2007
Est. completion date March 2009

Study information

Verified date February 2009
Source University of Bristol
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop a structured CBT group intervention for women with depression of mild or moderate severity and to pilot a randomized controlled trial to compare this intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 54 Years
Eligibility Inclusion Criteria:

- mild to moderate depression

- antidepressant use is also OK

Exclusion Criteria:

- able to speak english

- abusing drugs or alcohol

- using secondary mental health services

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief CBT Group therapy
CBT based therapy also expert patient programme

Locations

Country Name City State
United Kingdom Merrywood GP Practice Knowle West, Bristol
United Kingdom Wellspring Healthy Living Centre Bristol

Sponsors (1)

Lead Sponsor Collaborator
University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary PHQ-9 Score 3 months and 6 months No
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