Randomised controlled trial of a complex intervention for persistently depressed women of Pakistani origin
| ISRCTN | ISRCTN19172148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19172148 |
| Secondary identifying numbers | 0242003TAE006GATER |
- Submission date
- 08/09/2005
- Registration date
- 12/04/2006
- Last edited
- 09/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Gater
Scientific
Scientific
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/08/2004 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rawnsley Building
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Dr John Rogers
Head of the Research Office
University of Manchester
Christie Building
Oxford Road
Manchester
M13 9PT
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Research council
Medical Research Council (MRC) Trial Platform Grant TP192 (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | Yes | No |
