NCT02202694

Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

• 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 application of culturally-adapted CBT (CaCBTp) for use in Pakistan. Design: Randomized Control Trial Setting: Psychiatry Departments of General Hospitals in Karachi. Participants: A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a psychological intervention or treatment as usual arm. Intervention: Culturally Adapted Cognitive Behavioral Therapy (CBT) Outcome measure: Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)

Detailed description

The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis in Pakistan Primary : -To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan. Secondary: * To assess fidelity of culturally-adapted CBT for psychosis. * To further modify CaCBTp in accordance with findings of feasibility study 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 thirtysix participants will be recruited in the feasibility study and divided equally into two arms. This will ensure that, even after loss to follow-up, the investigators 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 twelve sessions of CaCBTp will be delivered by trained research clinician for a period of three months. Participants in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested Participants will be offered CaCBTp.

Conditions

• Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Culturally Adapted Cognitive behavior therapy	This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-07-29
• Last updated: 2017-01-16

Locations

1 site across 1 country: Pakistan