Clinical trial NCT01308151: Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm
Official title: Culturally Adapted Manual Assisted Cognitive Behavioral Therapy for Prevention of Self Harm: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attempted Suicide
Depression
Keywords: CBT, self harm, depression, cultural adaptation, Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Dow University of Health Sciences
name: Abbasi Shaheed Hospital
First posted: 2011-03-03
Enrollment: 221
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck scale for suicidal ideation
timeFrame: six months
Secondary outcomes:
measure: Quality of life (EQ 5 D)
timeFrame: six months
measure: Coping Resource Inventory (CRI)
timeFrame: six months
measure: CSRI Health care use Questionnaire
timeFrame: six months
measure: Para suicide history: interview
timeFrame: six months
measure: Hopelessness ( Beck hopelessness scale)
timeFrame: six months
measure: Beck Depression Inventory
timeFrame: six months
measure: PSI/SF
timeFrame: six months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Abbasi Shaheed Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
city: Karachi
country: Pakistan
facility: Pakistan Institute of Learning and Living
state: Sindh
city: Karachi
country: Pakistan
facility: Civil hospital
state: Sind
Study officials:
affiliation: Pakistan Institute of Learning and Living, University of Manchester
name: Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Nasim Chaudhry, MRCPsych, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Imran Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences Karachi
name: Salahuddin Afsar, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Meher Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Raza Ur-Rehman, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Batool Fatima
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Learning and Living, University of Southampton
name: Farooq Naeem, MRCPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbasi Shaheed Hospital
name: Munir Hamirani, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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, 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.
citation: 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.
citation: 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.