NCT00663078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for early_phase_1 depression

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 14, 2010

Status Verified

February 1, 2009

Enrollment Period

1.6 years

First QC Date

April 18, 2008

Last Update Submit

January 13, 2010

Conditions

DepressionAnxiety

Keywords

Cognitive Behavioral Therapyexpert patient programmedeprived populationwomen

Outcome Measures

Primary Outcomes (1)

  • PHQ-9 Score

    3 months and 6 months

Study Arms (2)

A

EXPERIMENTAL

Group A: Women from GP practices and area of Knowle West, Bristol

Behavioral: Brief CBT Group therapy

B

EXPERIMENTAL

Group B: Women from Wellspring, GP practice or geographical area of Barton Hill Bristol.

Behavioral: Brief CBT Group therapy

Interventions

Brief CBT Group therapyBEHAVIORAL

CBT based therapy also expert patient programme

AB

Eligibility Criteria

Age30 Years - 54 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mild to moderate depression
  • antidepressant use is also OK

You may not qualify if:

  • able to speak english
  • abusing drugs or alcohol
  • using secondary mental health services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Merrywood GP Practice Knowle West,

Bristol, bristol, BS, United Kingdom

Location

Wellspring Healthy Living Centre

Bristol, Bristol, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21569488DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

August 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 14, 2010

Record last verified: 2009-02

Locations

GB(2)