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Completed

NCT Number: NCT01308151

Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

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

Completed

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Key information

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbasi Shaheed Hospital, Karachi, Sindh, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

other

Other

No interventions other than the culturally adapted manualised cognitive behavioral therapy

Other names: C-MAP

Primary outcomes

  1. Beck scale for suicidal ideation

    Time frame: six months

    This is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.

Secondary outcomes

  1. Quality of life (EQ 5 D)

    Time frame: six months

    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.

  2. Coping Resource Inventory (CRI)

    Time frame: six months

    Assesses coping resources available for managing stress

  3. CSRI Health care use Questionnaire

    Time frame: six months

    An estimate of the health and social services received.

  4. Para suicide history: interview

    Time frame: six months

    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

  5. Hopelessness ( Beck hopelessness scale)

    Time frame: six months

    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.

  6. Beck Depression Inventory

    Time frame: six months

    21 item scale measuring symptoms of depression. Higher scores indicating greater severity of depression

  7. PSI/SF

    Time frame: six months

    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).

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Abbasi Shaheed Hospital
  • Dow University of Health Sciences
  • University of Manchester

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2011
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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