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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| Dow University of Health Sciences | OTHER |
| Abbasi Shaheed Hospital | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Culturally Adapted Cognitive Behavior Therapy |
|
| Control | No Intervention | Patients who will be randomized to the "treatment as usual" arm will receive routine care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally Adapted Cognitive behavior therapy | Behavioral | This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Psychotic Symptom Rating Scales (PSYRATS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow University of Health Sciences | Karachi | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29207980 | Derived | Husain MO, Chaudhry IB, Mehmood N, Rehman RU, Kazmi A, Hamirani M, Kiran T, Bukhsh A, Bassett P, Husain MI, Naeem F, Husain N. Pilot randomised controlled trial of culturally adapted cognitive behavior therapy for psychosis (CaCBTp) in Pakistan. BMC Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
Assesses Improvement in insight
| 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. | Baseline ,3 months & 6 months |
| Short Explanatory Model Interview | used to elicit beliefs of mental illness | Baseline ,3 months & 6 months |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000077765 | Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |