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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663078
First Posted: April 22, 2008
Last Update Posted: January 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bristol
  Purpose
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 Intervention Phase
Depression Anxiety Behavioral: Brief CBT Group therapy Early Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Bristol:

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

Enrollment: 75
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: April 18, 2008
First Posted: April 22, 2008
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