Psychosis Clinical Trial
Official title:
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)
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.
;
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