NCT00663078CompletedEarly Phase 1
A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression
Conditions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Bristol
- Enrollment
- 75
- Locations
- 3
- Primary Endpoint
- PHQ-9 Score
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 54 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
PHQ-9 Score
Time Frame: 3 months and 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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