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Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

P

Pakistan Institute of Living and Learning

Status

Completed

Conditions

Attempted Suicide
Depression

Treatments

Other: Other

Study type

Interventional

Funder types

Other

Identifiers

NCT01308151
PILL-UoM Self Harm 250410

Details and patient eligibility

About

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

Full 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.

Enrollment

221 patients

Sex

All

Ages

16 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

221 participants in 2 patient groups

Experimental Arm
Experimental group
Description:
Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
Treatment:
Other: Other
Control
No Intervention group
Description:
Patients who will be randomized to the "treatment as usual" arm will receive routine care

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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