- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202694
Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Dow University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
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
|
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
Other Names:
|
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
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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