Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
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|ClinicalTrials.gov Identifier: NCT02202694|
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : January 16, 2017
To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.
Randomized Control Trial
Psychiatry Departments of General Hospitals in Karachi.
A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a psychological intervention or treatment as usual arm.
Culturally Adapted Cognitive Behavioral Therapy (CBT)
Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)
|Condition or disease||Intervention/treatment||Phase|
|Psychosis||Behavioral: Culturally Adapted Cognitive behavior therapy||Not Applicable|
The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis in Pakistan
-To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.
- 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 (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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 Name: Psychosocial intervention
No Intervention: Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care
- 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.
- 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.
- Insight rating scale [ Time Frame: Baseline ,3 months & 6 months ]Assesses Improvement in insight
- 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.
- Short Explanatory Model Interview [ Time Frame: Baseline ,3 months & 6 months ]used to elicit beliefs of mental illness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202694
|Dow University of Health Sciences|
|Karachi, Sindh, Pakistan|
|Principal Investigator:||Nusrat Husain, MD||Pakistan Institute of Learning and Living, University of Manchester|
|Principal Investigator:||Imran Chaudhry, MD||University of Manchester|
|Principal Investigator:||Farooq Naeem, MRCPsych||Pakistan Institute of Learning and Living, University of Southampton|
|Principal Investigator:||Raza ur Rehman, FCPS||Dow University of Health Sciences|
|Principal Investigator:||Ajmal Kazmi||Pakistan Institute of Living and Learning|
|Principal Investigator:||Munir Hamirani, FCPS||Abbasi Shaheed Hospital|