Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm
- Conditions
- Attempted SuicideDepression
- Interventions
- Other: Other
- Registration Number
- NCT01308151
- Lead Sponsor
- Pakistan Institute of Living and Learning
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
-
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.
-
• 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Other Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
- Primary Outcome Measures
Name Time Method Beck scale for suicidal ideation six months This is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.
- Secondary Outcome Measures
Name Time Method Quality of life (EQ 5 D) 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.
Coping Resource Inventory (CRI) six months Assesses coping resources available for managing stress
Para suicide history: interview 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
Hopelessness ( Beck hopelessness scale) 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.
Beck Depression Inventory six months 21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression
PSI/SF 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).
CSRI Health care use Questionnaire six months An estimate of the health and social services received.
Trial Locations
- Locations (4)
Civil hospital
🇵🇰Karachi, Sind, Pakistan
Dow University of Health Sciences
🇵🇰Karachi, Sindh, Pakistan
Pakistan Institute of Learning and Living
🇵🇰Karachi, Sindh, Pakistan
Abbasi Shaheed Hospital
🇵🇰Karachi, Sindh, Pakistan