Clinical trial NCT02202694: Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Official title: Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: CBT, Psychosis, cultural adaptation, Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Dow University of Health Sciences
name: Abbasi Shaheed Hospital
First posted: 2014-07-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Positive and Negative syndrome scale (PANSS)
timeFrame: up to 6 months
Secondary outcomes:
measure: Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: Baseline ,3 months & 6 months
measure: Insight rating scale
timeFrame: Baseline ,3 months & 6 months
measure: Calgary Depression Scale for Schizophrenia
timeFrame: Baseline ,3 months & 6 months
measure: Short Explanatory Model Interview
timeFrame: Baseline ,3 months & 6 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Pakistan Institute of Learning and Living, University of Manchester
name: Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Imran Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Learning and Living, University of Southampton
name: Farooq Naeem, MRCPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Raza ur Rehman, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Ajmal Kazmi
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbasi Shaheed Hospital
name: Munir Hamirani, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.