Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02202694
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Study Overview
Official Title:
Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: