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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02742922
Acronym
C-MAP
Enrollment
901
Registered
2016-04-19
Start date
2016-04-27
Completion date
2019-10-30
Last updated
2023-05-19

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

Conditions

Self Harm

Keywords

self harm, culturally adapted therapy, problem solving therapy, low and middle income countries

Brief summary

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

Detailed description

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

Interventions

BEHAVIORALCulturally adapted therapy (C-MAP)

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.

Sponsors

University of Manchester
CollaboratorOTHER
Dow University of Health Sciences
CollaboratorOTHER
Karachi Medical and Dental College
CollaboratorOTHER
Services Hospital, Lahore
CollaboratorOTHER_GOV
Peshawar Medical College
CollaboratorOTHER
Pakistan Institute of Living and Learning
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients over the age of 18 years will be considered eligible for the study. 2. Participants will have to be living within the catchment area of the participating practices and hospitals. 3. Not needing inpatient psychiatric treatment.

Exclusion criteria

1. Temporary resident unlikely to be available for follow up. 2. 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. 3. Unable to engage, participate or respond to the research questionnaires.

Design outcomes

Primary

MeasureTime frameDescription
Suicide Attempt Self Injury Interview SASIIup to 12th monthsRepetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)

Secondary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026