Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: Culturally Adapted Cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Psychosis established by clinician using ICD10 criteria. Individuals aged between 18-65. Should not have learning disability. Resident of Karachi. Participant is able to give informed written consent Exclusion Criteria: Severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Culturally Adapted Cognitive Behavior Therapy | Behavioral: Culturally Adapted Cognitive behavior therapy<br>* This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component<br>* Other names: Psychosocial intervention;|
| No Intervention: Control<br>Patients who will be randomized to the treatment as usual arm will receive routine care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative syndrome scale (PANSS) | The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic Symptom Rating Scales (PSYRATS) | The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week. | Baseline ,3 months & 6 months | 
| Insight rating scale | Assesses Improvement in insight | Baseline ,3 months & 6 months | 
| Calgary Depression Scale for Schizophrenia | This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia. | Baseline ,3 months & 6 months | 
| Short Explanatory Model Interview | used to elicit beliefs of mental illness | Baseline ,3 months & 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Psychosis, cultural adaptation, Pakistan