Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

This study has been completed.
Sponsor:
Collaborators:
University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital
Information provided by:
Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier:
NCT01308151
First received: March 2, 2011
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Attempted Suicide
Depression
Other: Other

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Culturally Adapted Manual Assisted Cognitive Behavioral Therapy for Prevention of Self Harm: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Pakistan Institute of Learning and Living:

Primary Outcome Measures:
  • Beck scale for suicidal ideation [ Time Frame: six months ] [ Designated as safety issue: No ]
    This is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.


Secondary Outcome Measures:
  • Quality of life (EQ 5 D) [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.

  • Coping Resource Inventory (CRI) [ Time Frame: six months ] [ Designated as safety issue: No ]
    Assesses coping resources available for managing stress

  • CSRI Health care use Questionnaire [ Time Frame: six months ] [ Designated as safety issue: No ]
    An estimate of the health and social services received.

  • Para suicide history: interview [ Time Frame: six months ] [ Designated as safety issue: No ]
    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

  • Hopelessness ( Beck hopelessness scale) [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.

  • Beck Depression Inventory [ Time Frame: six months ] [ Designated as safety issue: No ]
    21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression

  • PSI/SF [ Time Frame: six months ] [ Designated as safety issue: No ]
    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).


Enrollment: 221
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm
Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
Other: Other
No interventions other than the culturally adapted manualised cognitive behavioral therapy
Other Name: C-MAP
No Intervention: Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care

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.

  Eligibility

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308151

Locations
Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan
Pakistan Institute of Learning and Living
Karachi, Sindh, Pakistan
Abbasi Shaheed Hospital
Karachi, Sindh, Pakistan
Civil hospital
Karachi, Sind, Pakistan, 75600
Sponsors and Collaborators
Pakistan Institute of Learning and Living
University of Manchester
Dow University of Health Sciences
Abbasi Shaheed Hospital
Investigators
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: Imran Chaudhry, MD University of Manchester
Principal Investigator: Salahuddin Afsar, FRCP Dow University of Health Sciences Karachi
Principal Investigator: Meher Husain, MD Pakistan Institute of Learning and Living
Principal Investigator: Raza Ur-Rehman, FCPS Dow University of Health Sciences
Principal Investigator: Batool Fatima Pakistan Institute of Learning and Living
Principal Investigator: Farooq Naeem, MRCPsych Pakistan Institute of Learning and Living, University of Southampton
Principal Investigator: Munir Hamirani, FCPS Abbasi Shaheed Hospital
  More Information

Publications:
Responsible Party: Dr. Nusrat Husain, Pakistan Institute Of Learning And Living
ClinicalTrials.gov Identifier: NCT01308151     History of Changes
Other Study ID Numbers: PILL-UoM Self Harm 250410
Study First Received: March 2, 2011
Last Updated: December 15, 2013
Health Authority: Pakistan: Ministry of Health

Keywords provided by Pakistan Institute of Learning and Living:
CBT, self harm, depression, cultural adaptation, Pakistan

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicide
Suicide, Attempted
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior

ClinicalTrials.gov processed this record on April 17, 2014