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

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

Detailed Description
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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

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

Conditions
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Self Harm

Intervention / Treatment
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* Behavioral: Culturally adapted therapy (C-MAP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally adapted therapy (C-MAP)<br>Culturally adapted manual assisted (C-MAP) brief problem solving therapy | Behavioral: Culturally adapted therapy (C-MAP)<br>* 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.<br>* Other names: psycho social intervention;|
| No Intervention: Treatment as usual<br>This arm will receive no intervention only TAٓU. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Attempt Self Injury Interview SASII | Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII) | up to 12th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Scale for Suicidal ideation (BSI). | 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. | Baseline, 3, 6, 9 and 12th months | 
| Beck Hopelessness Scale | This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression | Baseline,3rd,6th,9th and 12th months | 
| Beck Depression Inventory (BDI) | This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression | Baseline,3rd,6th,9th and 12th months | 
| EuroQol-5 Dimensions (EQ5-D) | 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). | Baseline,3rd,6th,9th and 12th months | 
| Coping Resource Inventory (CRI). | To assess the coping resources to manage stress available to an individual. | Baseline,3rd,6th,9th and 12th months | 
| Client Satisfaction Questionnaire (CSQ). | The participants will rate their satisfaction with treatment by using the CSQ. | Baseline,3rd,6th,9th and 12th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self harm, culturally adapted therapy, problem solving therapy, low and middle income countries