Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm
|ClinicalTrials.gov Identifier: NCT01308151|
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : December 17, 2013
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.
Patients who receive cognitive behavioral therapy will show significant decrease in suicidal ideation as compared to patients with treatment as usual.
Randomized Control Trial
Medical Departments of General Hospitals in Karachi.
A total of 200 self harm patients will be randomized to psychological intervention and treatment as usual arm.
Culturally Adapted Cognitive Behavioral Therapy (CBT)
Beck Suicidal Ideation Scale
|Condition or disease||Intervention/treatment|
|Attempted Suicide Depression||Other: Other|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Culturally Adapted Manual Assisted Cognitive Behavioral Therapy for Prevention of Self Harm: A Randomized Control Trial|
|Study Start Date :||March 2010|
|Primary Completion Date :||March 2012|
|Study Completion Date :||October 2012|
Experimental: Experimental Arm
Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
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
- 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.
- Quality of life (EQ 5 D) [ Time Frame: 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) [ Time Frame: six months ]Assesses coping resources available for managing stress
- CSRI Health care use Questionnaire [ Time Frame: six months ]An estimate of the health and social services received.
- Para suicide history: interview [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: six months ]21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression
- PSI/SF [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308151
|Abbasi Shaheed Hospital|
|Karachi, Sindh, Pakistan|
|Dow University of Health Sciences|
|Karachi, Sindh, Pakistan|
|Pakistan Institute of Learning and Living|
|Karachi, Sindh, Pakistan|
|Karachi, Sind, Pakistan, 75600|
|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|