- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01308151
Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm
Culturally Adapted Manual Assisted Cognitive Behavioral Therapy for Prevention of Self Harm: A Randomized Control Trial
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sind
-
Karachi, Sind, Pakistan, 75600
- Civil Hospital
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Dow University of Health Sciences
-
Karachi, Sindh, Pakistan
- Abbasi Shaheed Hospital
-
Karachi, Sindh, Pakistan
- Pakistan Institute of Learning and Living
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
No Intervention: Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
six months
|
Coping Resource Inventory (CRI)
Time Frame: six months
|
Assesses coping resources available for managing stress
|
six months
|
CSRI Health care use Questionnaire
Time Frame: six months
|
An estimate of the health and social services received.
|
six months
|
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
|
six months
|
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.
|
six months
|
Beck Depression Inventory
Time Frame: six months
|
21 item scale measuring symptoms of depression.
Higher scores indicating greater severity of depression
|
six months
|
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).
|
six months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Batool Fatima, Pakistan Institute of Living and Learning
- Principal Investigator: Imran Chaudhry, MD, University of Manchester
- 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: Salahuddin Afsar, FRCP, Dow University of Health Sciences Karachi
- Principal Investigator: Meher Husain, MD, Pakistan Institute of Living and Learning
- Principal Investigator: Raza Ur-Rehman, FCPS, Dow University of Health Sciences
- Principal Investigator: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- Principal Investigator: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
Publications and helpful links
General Publications
- Hawton K, Arensman E, Townsend E, Bremner S, Feldman E, Goldney R, Gunnell D, Hazell P, van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L. Deliberate self harm: systematic review of efficacy of psychosocial and pharmacological treatments in preventing repetition. BMJ. 1998 Aug 15;317(7156):441-7. doi: 10.1136/bmj.317.7156.441.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Rahman A, Iqbal Z, Waheed W, Hussain N. Translation and cultural adaptation of health questionnaires. J Pak Med Assoc. 2003 Apr;53(4):142-7.
- Guthrie E, Kapur N, Mackway-Jones K, Chew-Graham C, Moorey J, Mendel E, Francis FM, Sanderson S, Turpin C, Boddy G. Predictors of outcome following brief psychodynamic-interpersonal therapy for deliberate self-poisoning. Aust N Z J Psychiatry. 2003 Oct;37(5):532-6. doi: 10.1046/j.1440-1614.2003.01197.x.
- Husain N, Afsar S, Ara J, Fayyaz H, Rahman RU, Tomenson B, Hamirani M, Chaudhry N, Fatima B, Husain M, Naeem F, Chaudhry IB. Brief psychological intervention after self-harm: randomised controlled trial from Pakistan. Br J Psychiatry. 2014 Jun;204(6):462-70. doi: 10.1192/bjp.bp.113.138370. Epub 2014 Mar 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PILL-UoM Self Harm 250410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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