Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Quality of life, assessed by EuroQol (EQ-5D) at 12 weeks.
Overall trial start date
15/06/2008
Overall trial end date
15/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Depressed women aged 16-55
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
66
Participant exclusion criteria
Anyone leaving community within the next six months
Recruitment start date
15/06/2008
Recruitment end date
15/09/2008
Locations
Countries of recruitment
Pakistan
Trial participating centre
11-C
Karachi
74500
Pakistan
Sponsor information
Organisation
Remedial Centre (Pakistan)
Sponsor details
D-9
Block I
North Nazimabad
Karachi
74500
Pakistan
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Remedial Centre (Pakistan)
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