Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

NCT ID: NCT02202694

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Culturally Adapted Cognitive Behavior Therapy

Group Type: EXPERIMENTAL

Culturally Adapted Cognitive behavior therapy

Intervention Type: BEHAVIORAL

This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Control

Patients who will be randomized to the "treatment as usual" arm will receive routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Culturally Adapted Cognitive behavior therapy

This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Intervention Type: BEHAVIORAL

Other Intervention Names

Psychosocial intervention

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Psychosis established by clinician using ICD10 criteria.

2. Individuals aged between 18-65.

3. Should not have learning disability.

4. Resident of Karachi.

5. Participant is able to give informed written consent

Exclusion Criteria

1. Severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms.

2. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Dow University of Health Sciences

OTHER

Sponsor Role: collaborator

Abbasi Shaheed Hospital

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nusrat Husain, MD

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Learning and Living, University of Manchester

Imran Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Farooq Naeem, MRCPsych

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Learning and Living, University of Southampton

Raza ur Rehman, FCPS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Ajmal Kazmi

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Munir Hamirani, FCPS

Role: PRINCIPAL_INVESTIGATOR

Abbasi Shaheed Hospital

Locations

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Countries

Pakistan

References

Husain MO, Chaudhry IB, Mehmood N, Rehman RU, Kazmi A, Hamirani M, Kiran T, Bukhsh A, Bassett P, Husain MI, Naeem F, Husain N. Pilot randomised controlled trial of culturally adapted cognitive behavior therapy for psychosis (CaCBTp) in Pakistan. BMC Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z.

Reference Type: DERIVED

PMID: 29207980 (View on PubMed)

Other Identifiers

CBT-PSY-01

Identifier Type: -

Identifier Source: org_study_id