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Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

P

Pakistan Institute of Living and Learning

Status

Completed

Conditions

Psychosis

Treatments

Behavioral: Culturally Adapted Cognitive behavior therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02202694
CBT-PSY-01

Details and patient eligibility

About

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)

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosis of Psychosis established by clinician using ICD10 criteria.
  2. Individuals aged between 18-65.
  3. Should not have learning disability.
  4. Resident of Karachi.
  5. Participant is able to give informed written consent

Exclusion criteria

  1. Severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms.
  2. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Intervention
Experimental group
Description:
Culturally Adapted Cognitive Behavior Therapy
Treatment:
Behavioral: Culturally Adapted Cognitive behavior therapy
Control
No Intervention group
Description:
Patients who will be randomized to the "treatment as usual" arm will receive routine care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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