NCT02167347

Culturally Adapted Family Intervention For Psychosis

Pilot Study of Culturaly Adapted Family Intervention for Psychosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Aim: To assess the feasibility of culturally adapted Family Intervention for Psychosis. Design: Randomized Control Trial Setting: psychiatric department of different hospitals Participants: A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm. Intervention: Culturally Adapted Family Intervention for Psychosis Outcome measure: Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being \& Support(CWS)

Detailed description

The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis Primary Objective : * To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs. * To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention. * To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention

Conditions

• Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Family intervention	This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2014-06-19
• Last updated: 2015-08-25

Locations

1 site across 1 country: Pakistan