Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308151
• Other study ID #: PILL-UoM Self Harm 250410
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: December 15, 2013
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attempted Suicide
• Depression
• Suicide, Attempted

Intervention

Other:
• Other
No interventions other than the culturally adapted manualised cognitive behavioral therapy

Locations

Country	Name	City	State
Pakistan	Abbasi Shaheed Hospital	Karachi	Sindh
Pakistan	Civil hospital	Karachi	Sind
Pakistan	Dow University of Health Sciences	Karachi	Sindh
Pakistan	Pakistan Institute of Learning and Living	Karachi	Sindh

Sponsors (4)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living	Abbasi Shaheed Hospital, Dow University of Health Sciences, University of Manchester

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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, Träskman-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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Coping Resource Inventory (CRI)	Assesses coping resources available for managing stress	six months	No
Secondary	CSRI Health care use Questionnaire	An estimate of the health and social services received.	six months	No
Secondary	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	No
Secondary	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	No
Secondary	Beck Depression Inventory	21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression	six months	No
Secondary	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	No