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Attempted SuicideNCT01308151

Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

A study testing Other in people with Attempted Suicide and Depression, run by Pakistan Institute of Living and Learning at 4 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 64 years
Conditions the study is for
Attempted Suicide, Depression
What is being tested?
Other
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
4 sitesPakistan
Study dates
Mar 2010to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 64 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • • 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.

Trial locations and contacts

4 sites in 1 country.

Pakistan4 sites

  • Civil hospital

    Karachi, Sindh, 75600

  • Abbasi Shaheed Hospital

    Karachi, Sindh

  • Dow University of Health Sciences

    Karachi, Sindh

  • Pakistan Institute of Learning and Living

    Karachi, Sindh

Other trials in Pakistan

About this study

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

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.

Read more

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

Read the 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.

Being tested
Other
Keywords
CBT, self harm, depression, cultural adaptation, Pakistan
Medical subject headings
Suicide, Attempted, Depression, Color Vision Defects, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OtherOther

    Also called C-MAP

    No interventions other than the culturally adapted manualised cognitive behavioral therapy

Study groups in NCT01308151
Study groupRoleWhat they receive
Experimental ArmExperimentalCulturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
Receives: Other: Other
ControlNo interventionPatients who will be randomized to the "treatment as usual" arm will receive routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: six months

Secondary outcomes (7)

  1. 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.

    Measured: six months

  2. Coping Resource Inventory (CRI)

    Assesses coping resources available for managing stress

    Measured: six months

  3. CSRI Health care use Questionnaire

    An estimate of the health and social services received.

    Measured: six months

  4. 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

    Measured: six months

  5. 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.

    Measured: six months

  6. Beck Depression Inventory

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

    Measured: six months

  7. 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).

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308151
Sponsor's protocol ID
PILL-UoM Self Harm 250410
Status last verified
Dec 2013
First submitted
2 Mar 2011
Last updated
17 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12776898

  • 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.

    PubMed 14511080

  • 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.

    PubMed 9703526

  • 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.

    PubMed 33884617

  • 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.

    PubMed 24676964

Questions about this trial

What is this clinical trial studying?

A study testing Other in people with Attempted Suicide and Depression, run by Pakistan Institute of Living and Learning at 4 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck scale for suicidal ideation (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308151, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.

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