Social intervention for depressed women: Pilot randomised controlled trial
| ISRCTN | ISRCTN64846643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64846643 |
| Protocol serial number | N/A |
| Sponsor | Remedial Centre (Pakistan) |
| Funder | Remedial Centre (Pakistan) |
- 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
Scientific
11-C
6 Commercial Zamzama Lane
DHA
Phase 5
Karachi
74500
Pakistan
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, rater-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| 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: |
| Key secondary outcome measure(s) |
Quality of life, assessed by EuroQol (EQ-5D) at 12 weeks. |
| Completion date | 15/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 66 |
| Key inclusion criteria | Depressed women aged 16-55 |
| Key exclusion criteria | Anyone leaving community within the next six months |
| Date of first enrolment | 15/06/2008 |
| Date of final enrolment | 15/09/2008 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
11-C
Karachi
74500
Pakistan
74500
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
