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Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression (BackonTrack)
This study is currently recruiting participants.
Verified by University of Bristol, April 2008
First Received: April 18, 2008   No Changes Posted
Sponsored by: University of Bristol
Information provided by: University of Bristol
ClinicalTrials.gov Identifier: NCT00663078
  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

MedlinePlus related topics: Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Group A: Women from GP practices and area of Knowle West, Bristol
Behavioral: Brief CBT Group therapy
CBT based therapy also expert patient programme
B: Experimental
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

Contacts
Contact: Helen A Cramer, PhD 44-11-7331-3820 helen.cramer@bristol.ac.uk
Contact: Ricardo Araya, PhD, MRCPsych 44-011-7954-6702 R.Araya@bristol.ac.uk

Locations
United Kingdom
Wellspring Healthy Living Centre Recruiting
Bristol, United Kingdom
Contact: Peter Brindle            
Contact: Helen Cramer     44 -11-7331-3820     Helen.Cramer@bristol.ac.uk    
Merrywood GP Practice Knowle West, Recruiting
Bristol, United Kingdom, BS
Contact: Chris Salisbury, MD, MB.ChB, MSc, FRCGP     44-11-7331-3865     C.Salisbury@bristol.ac.uk    
Contact: Helen A Cramer, PhD     44-11-7331-3820     Helen.cramer@bristol.ac.uk    
Principal Investigator: Chris Salisbury, MD, MB.ChB, MSc, FRCGP            
Sponsors and Collaborators
University of Bristol
  More Information

No publications provided

Responsible Party: University of Bristol ( Professor Ricardo Araya )
Study ID Numbers: 07/H0107/60
Study First Received: April 18, 2008
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00663078     History of Changes
Health Authority: United Kingdom: Research Ethics Committee

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

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

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

ClinicalTrials.gov processed this record on May 07, 2009