|
ISRCTN
|
ISRCTN64846643
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Social intervention for depressed women: Pilot randomised controlled trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
There will be a reduction in depressive symptoms in a group of chronically depressed Pakistani women by attending a social group intervention at a local community centre.
|
|
Ethics approval
|
Approved by the Ethical Research Committee of Pakistan Institute of Learning and Living (PILL). Date of approval: 19/03/2008 (ref: PILL-080311)
|
|
Study design
|
Randomised, rater-blind trial
|
|
Countries of recruitment
|
Pakistan
|
|
Disease/condition/study domain
|
Depression
|
|
Participants - inclusion criteria
|
Depressed women aged 16-55
|
|
Participants - exclusion criteria
|
Anyone leaving community within the next six months
|
|
Anticipated start date
|
15/06/2008
|
|
Anticipated end date
|
15/09/2008
|
|
Status of trial
|
Completed
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
66
|
|
Interventions
|
The 66 participants will be divided into 3 groups (22 participants each), and then they will be randomly allocated to the intervention and control sub-groups (therefore, each sub-group consists of 11 participants). The control group will be provided with antidepressants and another will be provided with a psychosocial intervention.
Phychosocial intervention: The group structure will be informal, active participation by the women will be encouraged at all times. The facilitators will motivate and encourage these women. The overall aim would be to provide social support, stimulation, education on mental and physical health needs, problem solving training and possibly giving these women a break from their distressing environment. This will provide an opportunity for them to initiate a process of getting acquainted with other women, even making friends. We hope that some of these relationships would be long lasting and would continue even when the group ends. Total number of sessions: 10. Duration of each session is 1 hour.
Total duration of interventions: 12 weeks.
|
|
Primary outcome measure(s)
|
The following will be carried out before and after attendance at the social activities group for 10 sessions or taking antidepressants for 10 weeks:
1. Self Rating Questionnaire (SRQ)
2. Hamilton depression scale
|
|
Secondary outcome measure(s)
|
Quality of life, assessed by EuroQol (EQ-5D) at 12 weeks.
|
|
Sources of funding
|
Remedial Centre (Pakistan)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Nusrat
Hussain
|
|
Address
|
11-C
6 Commercial Zamzama Lane
DHA
Phase 5
|
|
City/town
|
Karachi
|
|
Zip/Postcode
|
74500
|
|
Country
|
Pakistan
|
|
Sponsor
|
Remedial Centre (Pakistan)
|
|
Address
|
D-9, Block I
North Nazimabad
|
|
City/town
|
Karachi
|
|
Zip/Postcode
|
74500
|
|
Country
|
Pakistan
|
|
Sponsor website:
|
http://remedialcentre.com
|
|
Date applied
|
07/06/2008
|
|
Last edited
|
11/07/2008
|
|
Date ISRCTN assigned
|
24/06/2008
|
