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Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression (BackonTrack)

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ClinicalTrials.gov Identifier: NCT00663078
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
University of Bristol

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Brief CBT Group therapy Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression
Study Start Date : August 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Group A: Women from GP practices and area of Knowle West, Bristol
Behavioral: Brief CBT Group therapy
CBT based therapy also expert patient programme
Experimental: B
Group B: Women from Wellspring, GP practice or geographical area of Barton Hill Bristol.
Behavioral: Brief CBT Group therapy
CBT based therapy also expert patient programme



Primary Outcome Measures :
  1. PHQ-9 Score [ Time Frame: 3 months and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663078


Locations
United Kingdom
Merrywood GP Practice Knowle West,
Bristol, United Kingdom, BS
Wellspring Healthy Living Centre
Bristol, United Kingdom
Sponsors and Collaborators
University of Bristol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Ricardo Araya, University of Bristol
ClinicalTrials.gov Identifier: NCT00663078     History of Changes
Other Study ID Numbers: 07/H0107/60
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: February 2009

Keywords provided by University of Bristol:
Cognitive Behavioral Therapy
expert patient programme
deprived population
women

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders