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Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

Primary Purpose

Psychosis

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Culturally Adapted Cognitive behavior therapy

About this trial

This is an interventional treatment trial for Psychosis focused on measuring CBT, Psychosis, cultural adaptation, Pakistan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Culturally Adapted Cognitive Behavior Therapy

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Psychotic Symptom Rating Scales (PSYRATS)

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

Insight rating scale

Assesses Improvement in insight

Calgary Depression Scale for Schizophrenia

This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.

Short Explanatory Model Interview

used to elicit beliefs of mental illness

Full Information

NCT ID

NCT02202694

First Posted

April 15, 2014

Last Updated

January 13, 2017

Sponsor

Pakistan Institute of Living and Learning

Collaborators

University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02202694

Brief Title

Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pakistan Institute of Living and Learning

Collaborators

University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychosis

Keywords

CBT, Psychosis, cultural adaptation, Pakistan

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Culturally Adapted Cognitive Behavior Therapy

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Culturally Adapted Cognitive behavior therapy

Other Intervention Name(s)

Psychosocial intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Positive and Negative syndrome scale (PANSS)

Description

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 Outcome Measure Information:

Title

Psychotic Symptom Rating Scales (PSYRATS)

Description

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

Title

Insight rating scale

Description

Assesses Improvement in insight

Time Frame

Baseline ,3 months & 6 months

Title

Calgary Depression Scale for Schizophrenia

Description

This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.

Time Frame

Baseline ,3 months & 6 months

Title

Short Explanatory Model Interview

Description

used to elicit beliefs of mental illness

Time Frame

Baseline ,3 months & 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials: