Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0242003TAE006GATER
Study information
Scientific title
Acronym
Study hypothesis
For depressed Pakistani women:
1. The beneficial effects on severity of depression and social functioning of social group therapy including psycho-education exceed those of protocol guided antidepressant treatment
2. The beneficial effects of combined social therapy group with protocol guided antidepressant treatment exceed those of social group therapy alone
Ethics approval
Ethics approval not yet received as of 12/04/06
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Depressive disorder
Intervention
Participants will be randomly allocated to one of three intervention groups:
1. Social group and psycho-education
2. Protocol-guided antidepressant treatment
3. Combined social group, psycho-education and protocol-guided antidepressant treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Severity of depression as measured by the Hamilton depression scale.
Secondary outcome measures
1. Social functioning measured by Bolton's social functioning questionnaire
2. Disability measured by the brief disability questionnaire and disability days
3. Service contacts measured by a modified version of the client service receipt inventory
Overall trial start date
01/08/2004
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Adult females, aged between 16 and 65, of Pakistani family origin who have a current depressive disorder.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Women who are pregnant or who are planning to become pregnant during the next six months
2. Women planning a trip away from Manchester for six weeks or more within the next six months (e.g. trip to Pakistan)
Recruitment start date
01/08/2004
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rawnsley Building
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Dr John Rogers
Head of the Research Office
University of Manchester
Christie Building
Oxford Road
Manchester
M13 9PT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) Trial Platform Grant TP192 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20807969
Publication citations
-
Results
Gater R, Waheed W, Husain N, Tomenson B, Aseem S, Creed F, Social intervention for British Pakistani women with depression: randomised controlled trial., Br J Psychiatry, 2010, 197, 3, 227-233, doi: 10.1192/bjp.bp.109.066845.