Social intervention for depressed women: Pilot randomised controlled trial

ISRCTN ISRCTN64846643
DOI https://doi.org/10.1186/ISRCTN64846643
Secondary identifying numbers N/A
Submission date
07/06/2008
Registration date
24/06/2008
Last edited
11/07/2008
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nusrat Hussain
Scientific

11-C
6 Commercial Zamzama Lane
DHA
Phase 5
Karachi
74500
Pakistan

Study information

Study designRandomised, rater-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThere 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(s)Approved by the Ethical Research Committee of Pakistan Institute of Learning and Living (PILL). Date of approval: 19/03/2008 (ref: PILL-080311)
Health condition(s) or problem(s) studiedDepression
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresQuality of life, assessed by EuroQol (EQ-5D) at 12 weeks.
Overall study start date15/06/2008
Completion date15/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants66
Key inclusion criteriaDepressed women aged 16-55
Key exclusion criteriaAnyone leaving community within the next six months
Date of first enrolment15/06/2008
Date of final enrolment15/09/2008

Locations

Countries of recruitment

  • Pakistan

Study participating centre

11-C
Karachi
74500
Pakistan

Sponsor information

Remedial Centre (Pakistan)
Hospital/treatment centre

D-9, Block I
North Nazimabad
Karachi
74500
Pakistan

Website http://remedialcentre.com
ROR logo "ROR" https://ror.org/03wdref81

Funders

Funder type

Hospital/treatment centre

Remedial Centre (Pakistan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan