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CompletedNCT02202694Updated Jan 16, 2017

Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan

An interventional study of Culturally Adapted Cognitive behavior therapy in Psychosis, sponsored by Pakistan Institute of Living and Learning. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-16.

Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Psychosis

Keywords

  • CBT, Psychosis, cultural adaptation, Pakistan
03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's enrollment of 36 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Intervention

    Culturally Adapted Cognitive Behavior Therapy

    Behavioral: Culturally Adapted Cognitive behavior therapy

  • No intervention
    Control

    Patients who will be randomized to the "treatment as usual" arm will receive routine care

Interventions

  • BehavioralCulturally Adapted Cognitive behavior therapy

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

    Also known as: Psychosocial intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 6 months

Secondary outcomes

  1. Psychotic Symptom Rating Scales (PSYRATS)

    The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.

    Time frame: Baseline ,3 months & 6 months

  2. Insight rating scale

    Assesses Improvement in insight

    Time frame: Baseline ,3 months & 6 months

  3. Calgary Depression Scale for Schizophrenia

    This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.

    Time frame: Baseline ,3 months & 6 months

  4. Short Explanatory Model Interview

    used to elicit beliefs of mental illness

    Time frame: Baseline ,3 months & 6 months

07

Study locations

1 site
  • Dow University of Health Sciences
    Karachi, Sindh, Pakistan
08

References and documents

Publications

  • 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. PubMed 29207980 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02202694
Lead sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
Responsible party
Sponsor
First posted
Jul 29, 2014
Start date
Mar 2012
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Jan 16, 2017

Study contacts

Nusrat Husain, MD
principal investigator · Pakistan Institute of Learning and Living, University of Manchester
Imran Chaudhry, MD
principal investigator · University of Manchester
Farooq Naeem, MRCPsych
principal investigator · Pakistan Institute of Learning and Living, University of Southampton
Raza ur Rehman, FCPS
principal investigator · Dow University of Health Sciences
Ajmal Kazmi
principal investigator · Pakistan Institute of Living and Learning
Munir Hamirani, FCPS
principal investigator · Abbasi Shaheed Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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