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Clinical Trials/NCT01308151
NCT01308151
Completed
N/A

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

Pakistan Institute of Living and Learning4 sites in 1 country221 target enrollmentMarch 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attempted Suicide
Sponsor
Pakistan Institute of Living and Learning
Enrollment
221
Locations
4
Primary Endpoint
Beck scale for suicidal ideation
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
October 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quality of life (EQ 5 D)(six months)
  • Coping Resource Inventory (CRI)(six months)
  • Para suicide history: interview(six months)
  • Hopelessness ( Beck hopelessness scale)(six months)
  • Beck Depression Inventory(six months)
  • PSI/SF(six months)
  • CSRI Health care use Questionnaire(six months)

Study Sites (4)

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