Condition category
Mental and Behavioural Disorders
Date applied
07/06/2008
Date assigned
24/06/2008
Last edited
11/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nusrat Hussain

ORCID ID

Contact details

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

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

http://remedialcentre.com

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

Publication citations

Additional files

Editorial Notes