Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

N/ACompletedNCT02202694

Pakistan Institute of Living and Learning36 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Psychosis

Interventions

Culturally Adapted Cognitive behavior therapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

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.

Time frame: up to 6 months

Secondary Outcomes

Psychotic Symptom Rating Scales (PSYRATS)

The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.

Time frame: Baseline ,3 months & 6 months

Insight rating scale

Assesses Improvement in insight

Time frame: 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.

Time frame: Baseline ,3 months & 6 months

Short Explanatory Model Interview

used to elicit beliefs of mental illness

Time frame: Baseline ,3 months & 6 months

Data from ClinicalTrials.gov

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