Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Attempted Suicide, Depression

Intervention / Treatment
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* Other: Other


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck scale for suicidal ideation | 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) | 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) | Assesses coping resources available for managing stress | six months | 
| CSRI Health care use Questionnaire | An estimate of the health and social services received. | six months | 
| Para suicide history: interview | 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) | 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 | 21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression | six months | 
| PSI/SF | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, self harm, depression, cultural adaptation, Pakistan