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Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202694
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : January 16, 2017
Sponsor:
Collaborators:
University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

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)


Condition or disease Intervention/treatment Phase
Psychosis Behavioral: Culturally Adapted Cognitive behavior therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Culturally Adapted Cognitive Behavior Therapy
Behavioral: Culturally Adapted Cognitive behavior therapy
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
Other Name: Psychosocial intervention

No Intervention: Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care



Primary Outcome Measures :
  1. Positive and Negative syndrome scale (PANSS) [ Time Frame: up to 6 months ]
    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.


Secondary Outcome Measures :
  1. Psychotic Symptom Rating Scales (PSYRATS) [ Time Frame: Baseline ,3 months & 6 months ]
    The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.

  2. Insight rating scale [ Time Frame: Baseline ,3 months & 6 months ]
    Assesses Improvement in insight

  3. Calgary Depression Scale for Schizophrenia [ Time Frame: Baseline ,3 months & 6 months ]
    This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.

  4. Short Explanatory Model Interview [ Time Frame: Baseline ,3 months & 6 months ]
    used to elicit beliefs of mental illness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202694


Locations
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Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning
University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital
Investigators
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Principal Investigator: Nusrat Husain, MD Pakistan Institute of Learning and Living, University of Manchester
Principal Investigator: Imran Chaudhry, MD University of Manchester
Principal Investigator: Farooq Naeem, MRCPsych Pakistan Institute of Learning and Living, University of Southampton
Principal Investigator: Raza ur Rehman, FCPS Dow University of Health Sciences
Principal Investigator: Ajmal Kazmi Pakistan Institute of Living and Learning
Principal Investigator: Munir Hamirani, FCPS Abbasi Shaheed Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT02202694    
Other Study ID Numbers: CBT-PSY-01
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: July 2014
Keywords provided by Pakistan Institute of Living and Learning:
CBT, Psychosis, cultural adaptation, Pakistan
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders