Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

NCT01308151 | Completed

• 1 other identifier: PILL-UoM Self Harm 250410
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 4

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

Conditions

Attempted Suicide; Depression

Keywords

CBT, self harm, depression, cultural adaptation, Pakistan

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Quality of life (EQ 5 D)

  six months

• Coping Resource Inventory (CRI)

  six months

• CSRI Health care use Questionnaire

  six months

• Para suicide history: interview

  six months

• Hopelessness ( Beck hopelessness scale)

  six months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.

Other: Other

Control

NO INTERVENTION

Patients who will be randomized to the "treatment as usual" arm will receive routine care

Interventions

Other OTHER

No interventions other than the culturally adapted manualised cognitive behavioral therapy

Also known as: C-MAP

Experimental Arm

Eligibility Criteria

• Age: 16 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• University of Manchester: collaborator
• Dow University of Health Sciences: collaborator
• Abbasi Shaheed Hospital: collaborator

Study Sites (4)

Civil hospital

Karachi, Sindh, 75600, Pakistan

Location

Abbasi Shaheed Hospital

Karachi, Sindh, Pakistan

Location

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Pakistan Institute of Learning and Living

Karachi, Sindh, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 12776898 BACKGROUND

• 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.

  PMID: 14511080 BACKGROUND

• 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.

  PMID: 9703526 BACKGROUND

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 24676964 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Depression; Color Vision Defects; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 Living and Learning

  PRINCIPAL INVESTIGATOR

• Raza Ur-Rehman, FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Batool Fatima

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

• Farooq Naeem, MRCPsych

  Pakistan Institute of Learning and Living, University of Southampton

  PRINCIPAL INVESTIGATOR

• Munir Hamirani, FCPS

  Abbasi Shaheed Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 3, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

PA (4)