Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

December 15, 2013 updated by: Pakistan Institute of Living and Learning

Culturally Adapted Manual Assisted Cognitive Behavioral Therapy for Prevention of Self Harm: A Randomized Control Trial

Aim:

To adapt and develop a culturally appropriate psychological intervention and test its feasibility, and acceptability for the patients presenting to general hospital following self-harm in Karachi Pakistan.

Primary hypothesis:

Patients who receive cognitive behavioral therapy will show significant decrease in suicidal ideation as compared to patients with treatment as usual.

Design:

Randomized Control Trial

Setting:

Medical Departments of General Hospitals in Karachi.

Participants:

A total of 200 self harm patients will be randomized to psychological intervention and treatment as usual arm.

Intervention:

Culturally Adapted Cognitive Behavioral Therapy (CBT)

Outcome measure:

Beck Suicidal Ideation Scale

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Culturally Adapted manualised Cognitive Behavioral Therapy (CBT) will be a brief problem focused therapy comprising of 6 sessions within three months after a self-harm episode. The adapted therapy/training will be delivered by therapists/trained counselors at the hospital. Sessions will be offered weekly in the first two weeks and than fortnightly and will last 50 minutes. During each session the therapists will assess the risk of suicide and will liaise with the research supervisor and patient's treating clinician.

The areas covered by the manual which has been adapted include an evaluation of the self-harm attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions and negative thinking and relapse prevention strategies. The treatment will be structured around patient's current problems with the relevant sections of the manual helping the patient to deal with specific problems leading to the self-harm act. Between the sessions the manual can be used for homework tasks by the patient.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sind
      • Karachi, Sind, Pakistan, 75600
        • Civil Hospital
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences
      • Karachi, Sindh, Pakistan
        • Abbasi Shaheed Hospital
      • Karachi, Sindh, Pakistan
        • Pakistan Institute of Learning and Living

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An episode of self harm within 48 hours before being admitted at the department;

    • age of 16 to 64 years;
    • Resident in the trial site catchments area,
    • Ability to complete a baseline assessment;
    • Ability to provide at least 2 verifiable contacts to improve tracking for subsequent assessments; and ability to understand and provide informed consent.

Exclusion Criteria:

  • • A medical disorder that would prevent participation in an outpatient clinical trial.

    • Temporary resident unlikely to be available for follow up.
    • Diagnosis of Alcohol and other drug dependence, schizophrenia or Bipolar Disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
No interventions other than the culturally adapted manualised cognitive behavioral therapy
Other Names:
  • C-MAP
No Intervention: Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck scale for suicidal ideation
Time Frame: six months
This is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (EQ 5 D)
Time Frame: six months
It is a measure of health and quality of life. This is a standardised instrument for use as a measure of health outcome; it provides a simple descriptive profile and a single index value for health status.
six months
Coping Resource Inventory (CRI)
Time Frame: six months
Assesses coping resources available for managing stress
six months
CSRI Health care use Questionnaire
Time Frame: six months
An estimate of the health and social services received.
six months
Para suicide history: interview
Time Frame: six months
This records all self harm events in a chronological order and can be used to assess both the time of first repeat self harm episode and the number of episodes over time together with the severity of episodes if required
six months
Hopelessness ( Beck hopelessness scale)
Time Frame: six months
This is a self-report instrument that consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future during the past week.
six months
Beck Depression Inventory
Time Frame: six months
21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression
six months
PSI/SF
Time Frame: six months
This is a brief version of parenting stress index. It has 36 items which measure four domains including family stress, general symptomotology (child), parent-child relationship and validity (caregiver).
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Batool Fatima, Pakistan Institute of Living and Learning
  • Principal Investigator: Imran Chaudhry, MD, University of Manchester
  • Principal Investigator: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
  • Principal Investigator: Nasim Chaudhry, MRCPsych, MD, University of Manchester
  • Principal Investigator: Salahuddin Afsar, FRCP, Dow University of Health Sciences Karachi
  • Principal Investigator: Meher Husain, MD, Pakistan Institute of Living and Learning
  • Principal Investigator: Raza Ur-Rehman, FCPS, Dow University of Health Sciences
  • Principal Investigator: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
  • Principal Investigator: Munir Hamirani, FCPS, Abbasi Shaheed Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 3, 2011

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 15, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • PILL-UoM Self Harm 250410

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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