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Completed

NCT Number: NCT02202694

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)

Completed

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Key information

Conditions

Psychosis Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Culturally Adapted Cognitive behavior therapy

Behavioral

This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component

Other names: Psychosocial intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Abbasi Shaheed Hospital
  • Dow University of Health Sciences
  • University of Manchester

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2014
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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