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Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

Primary Purpose

Attempted Suicide, Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Other
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attempted Suicide focused on measuring CBT, self harm, depression, cultural adaptation, Pakistan

Eligibility Criteria

16 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abbasi Shaheed Hospital
  • Dow University of Health Sciences
  • Pakistan Institute of Learning and Living
  • Civil hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Arm

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Coping Resource Inventory (CRI)
Assesses coping resources available for managing stress
CSRI Health care use Questionnaire
An estimate of the health and social services received.
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
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.
Beck Depression Inventory
21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression
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).

Full Information

First Posted
March 2, 2011
Last Updated
December 15, 2013
Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01308151
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attempted Suicide, Depression
Keywords
CBT, self harm, depression, cultural adaptation, Pakistan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients who will be randomized to the "treatment as usual" arm will receive routine care
Intervention Type
Other
Intervention Name(s)
Other
Other Intervention Name(s)
C-MAP
Intervention Description
No interventions other than the culturally adapted manualised cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Beck scale for suicidal ideation
Description
This is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Quality of life (EQ 5 D)
Description
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.
Time Frame
six months
Title
Coping Resource Inventory (CRI)
Description
Assesses coping resources available for managing stress
Time Frame
six months
Title
CSRI Health care use Questionnaire
Description
An estimate of the health and social services received.
Time Frame
six months
Title
Para suicide history: interview
Description
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
Time Frame
six months
Title
Hopelessness ( Beck hopelessness scale)
Description
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.
Time Frame
six months
Title
Beck Depression Inventory
Description
21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression
Time Frame
six months
Title
PSI/SF
Description
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).
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nusrat Husain, MD
Organizational Affiliation
Pakistan Institute of Learning and Living, University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasim Chaudhry, MRCPsych, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Imran Chaudhry, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salahuddin Afsar, FRCP
Organizational Affiliation
Dow University of Health Sciences Karachi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meher Husain, MD
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raza Ur-Rehman, FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Batool Fatima
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farooq Naeem, MRCPsych
Organizational Affiliation
Pakistan Institute of Learning and Living, University of Southampton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Munir Hamirani, FCPS
Organizational Affiliation
Abbasi Shaheed Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbasi Shaheed Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Pakistan Institute of Learning and Living
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Civil hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
75600
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
12776898
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.
Results Reference
background
PubMed Identifier
14511080
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.
Results Reference
background
PubMed Identifier
9703526
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.
Results Reference
background
PubMed Identifier
33884617
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.
Results Reference
derived
PubMed Identifier
24676964
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.
Results Reference
derived

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Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

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