Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

Psychosis Clinical Trial

Official title:

Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202694
• Other study ID #: CBT-PSY-01
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: January 13, 2017
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Culturally Adapted Cognitive behavior therapy
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (4)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living	Abbasi Shaheed Hospital, Dow University of Health Sciences, University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Insight rating scale	Assesses Improvement in insight	Baseline ,3 months & 6 months
Secondary	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
Secondary	Short Explanatory Model Interview	used to elicit beliefs of mental illness	Baseline ,3 months & 6 months