Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

January 13, 2017 updated by: Pakistan Institute of Living and Learning

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative syndrome scale (PANSS)
Time Frame: up to 6 months
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)
Time Frame: Baseline ,3 months & 6 months
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
Time Frame: Baseline ,3 months & 6 months
Assesses Improvement in insight
Baseline ,3 months & 6 months
Calgary Depression Scale for Schizophrenia
Time Frame: Baseline ,3 months & 6 months
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
Time Frame: Baseline ,3 months & 6 months
used to elicit beliefs of mental illness
Baseline ,3 months & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Collaborators

University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital

Investigators

  • Principal Investigator: Imran Chaudhry, MD, University of Manchester
  • Principal Investigator: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
  • Principal Investigator: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
  • Principal Investigator: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
  • Principal Investigator: Raza Ur Rehman, FCPS, Dow University of Health Sciences
  • Principal Investigator: Ajmal Kazmi, Pakistan Institute of Living and Learning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-PSY-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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