Randomised controlled trial of a complex intervention for persistently depressed women of Pakistani origin

ISRCTN	ISRCTN19172148
DOI	https://doi.org/10.1186/ISRCTN19172148
Protocol serial number	0242003TAE006GATER
Sponsor	University of Manchester (UK)
Funder	Medical Research Council (MRC) Trial Platform Grant TP192 (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Richard Gater
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval not yet received as of 12/04/06
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Severity of depression as measured by the Hamilton depression scale.
Key secondary outcome measure(s)	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
Completion date	31/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	120
Key inclusion criteria	Adult females, aged between 16 and 65, of Pakistani family origin who have a current depressive disorder.
Key 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)
Date of first enrolment	01/08/2004
Date of final enrolment	31/07/2006

Rawnsley Building

Manchester
M13 9WL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2010		Yes	No