NCT02202694

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
Last Updated

January 16, 2017

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

April 15, 2014

Last Update Submit

January 13, 2017

Conditions

Psychosis

Keywords

CBT, Psychosis, cultural adaptation, Pakistan

Outcome Measures

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.

    up to 6 months

Secondary Outcomes (4)

  • Psychotic Symptom Rating Scales (PSYRATS)

    Baseline ,3 months & 6 months

  • Insight rating scale

    Baseline ,3 months & 6 months

  • Calgary Depression Scale for Schizophrenia

    Baseline ,3 months & 6 months

  • Short Explanatory Model Interview

    Baseline ,3 months & 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Culturally Adapted Cognitive Behavior Therapy

Behavioral: Culturally Adapted Cognitive behavior therapy

Control

NO INTERVENTION

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

Interventions

Culturally Adapted Cognitive behavior therapyBEHAVIORAL

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

Also known as: Psychosocial intervention
Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 29207980DERIVED

MeSH Terms

Conditions

Psychotic DisordersColor Vision Defects

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophyEye Diseases, HereditaryEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

July 29, 2014

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 16, 2017

Record last verified: 2014-07

Locations

PA(1)