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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01308151
Enrollment
221
Registered
2011-03-03
Start date
2010-03-31
Completion date
2012-10-31
Last updated
2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attempted Suicide, Depression

Keywords

CBT, self harm, depression, cultural adaptation, Pakistan

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.

Interventions

OTHEROther

No interventions other than the culturally adapted manualised cognitive behavioral therapy

Sponsors

University of Manchester
CollaboratorOTHER
Dow University of Health Sciences
CollaboratorOTHER
Abbasi Shaheed Hospital
CollaboratorOTHER
Pakistan Institute of Living and Learning
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Beck scale for suicidal ideationsix monthsThis is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.

Secondary

MeasureTime frameDescription
Coping Resource Inventory (CRI)six monthsAssesses coping resources available for managing stress
CSRI Health care use Questionnairesix monthsAn estimate of the health and social services received.
Para suicide history: interviewsix monthsThis 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
Quality of life (EQ 5 D)six monthsIt 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.
Beck Depression Inventorysix months21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression
PSI/SFsix monthsThis 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).
Hopelessness ( Beck hopelessness scale)six monthsThis 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026