Condition category
Mental and Behavioural Disorders
Date applied
08/09/2005
Date assigned
12/04/2006
Last edited
09/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Gater

ORCID ID

Contact details

Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

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

http://www.manchester.ac.uk/

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

  1. 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.

Additional files

Editorial Notes