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

This study has been completed.
Sponsor:
Information provided by:
University of Bristol
ClinicalTrials.gov Identifier:
NCT00663078
First received: April 18, 2008
Last updated: January 13, 2010
Last verified: February 2009
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by University of Bristol:

Primary Outcome Measures:
  • PHQ-9 Score [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 54 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663078

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

No publications provided by University of Bristol

Additional 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
Study First Received: April 18, 2008
Last Updated: January 13, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013