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Completed

NCT Number: NCT02742922

Multicenter Study to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP)

To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolan Medical Complex, Quetta, Balochistan, Pakistan

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About this study

Suicide is a serious global public health issue, ranked amongst the leading causes of death in many countries. Most of these (75%) are in the low and middle income countries (LAMIC) and globally suicide is the second leading cause of death in young people 15-29 years of age. There is no official data on suicide from Pakistan, a conservative South Asian Islamic country with historically low suicide rates. Both suicide and attempted suicide are illegal acts, as well as socially and religiously condemned, however, there is accumulating evidence that suicide rates have been gradually increasing in Pakistan over the last few years.

The culturally adapted psychological intervention C-MAP utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice. Our previous pilot trial in Karachi shows the efficacy of CBT based intervention(C-MAP) in people who had recently self harmed.The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over the age of 18 years will be considered eligible for the study.
  • Participants will have to be living within the catchment area of the participating practices and hospitals.
  • Not needing inpatient psychiatric treatment.

Exclusion criteria

  • Temporary resident unlikely to be available for follow up.
  • Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
  • Unable to engage, participate or respond to the research questionnaires.

Treatment and study plan

Culturally adapted therapy (C-MAP)

Behavioral

C-MAP is a brief problem focused therapy, comprising of six sessions delivered within three months. C-MAP is a manual assisted intervention based on the principles of CBT .In this intervention there is an evaluation of the self-harm attempt, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.

Other names: psycho social intervention

Primary outcomes

  1. Suicide Attempt Self Injury Interview SASII

    Time frame: up to 12th months

    Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)

Secondary outcomes

  1. Beck Scale for Suicidal ideation (BSI).

    Time frame: Baseline, 3, 6, 9 and 12th months

    This is a 19-item instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviours, and specificity of a patient's thoughts to kill him/herself during the past week.

  2. Beck Hopelessness Scale

    Time frame: Baseline,3rd,6th,9th and 12th months

    This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression

  3. Beck Depression Inventory (BDI)

    Time frame: Baseline,3rd,6th,9th and 12th months

    This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression

  4. EuroQol-5 Dimensions (EQ5-D)

    Time frame: Baseline,3rd,6th,9th and 12th months

    A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression).

  5. Coping Resource Inventory (CRI).

    Time frame: Baseline,3rd,6th,9th and 12th months

    To assess the coping resources to manage stress available to an individual.

  6. Client Satisfaction Questionnaire (CSQ).

    Time frame: Baseline,3rd,6th,9th and 12th months

    The participants will rate their satisfaction with treatment by using the CSQ.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Dow University of Health Sciences
  • Karachi Medical and Dental College
  • Peshawar Medical College
  • Services Hospital, Lahore
  • University of Manchester

Registry information

Official study title

Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm

Acronym: C-MAP

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
May 19, 2023

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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