Back to resultsGroup Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression (BackonTrack)
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Brief CBT Group therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Cognitive Behavioral Therapy, expert patient programme, deprived population, women
Eligibility Criteria
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
Sites / Locations
- Merrywood GP Practice Knowle West,
- Wellspring Healthy Living Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Group A: Women from GP practices and area of Knowle West, Bristol
Group B: Women from Wellspring, GP practice or geographical area of Barton Hill Bristol.
Outcomes
Primary Outcome Measures
PHQ-9 Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663078
Brief Title
Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression
Acronym
BackonTrack
Official Title
A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bristol
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Cognitive Behavioral Therapy, expert patient programme, deprived population, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Group A: Women from GP practices and area of Knowle West, Bristol
Arm Title
B
Arm Type
Experimental
Arm Description
Group B: Women from Wellspring, GP practice or geographical area of Barton Hill Bristol.
Intervention Type
Behavioral
Intervention Name(s)
Brief CBT Group therapy
Intervention Description
CBT based therapy also expert patient programme
Primary Outcome Measure Information:
Title
PHQ-9 Score
Time Frame
3 months and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Merrywood GP Practice Knowle West,
City
Bristol
ZIP/Postal Code
BS
Country
United Kingdom
Facility Name
Wellspring Healthy Living Centre
City
Bristol
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21569488
Citation
Cramer H, Salisbury C, Conrad J, Eldred J, Araya R. Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods. BMC Psychiatry. 2011 May 13;11:82. doi: 10.1186/1471-244X-11-82.
Results Reference
derived
Learn more about this trial
Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression
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