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

Not Applicable

Completed

• Conditions: Self Harm
• Interventions: Behavioral: Culturally adapted therapy (C-MAP)

• Registration Number: NCT02742922
• Lead Sponsor: Pakistan Institute of Living and Learning

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

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Study Start: 2016-04-27
• Primary Completion: 2019-07-30
• Study Completion: 2019-10-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 901

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culturally adapted therapy (C-MAP)	Culturally adapted therapy (C-MAP)	Culturally adapted manual assisted (C-MAP) brief problem solving therapy

Primary Outcome Measures

Name	Time	Method
Suicide Attempt Self Injury Interview SASII	up to 12th months	Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)

Secondary Outcome Measures

Name	Time	Method
Beck Scale for Suicidal ideation (BSI).	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.
Beck Hopelessness Scale	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
Beck Depression Inventory (BDI)	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
Coping Resource Inventory (CRI).	Baseline,3rd,6th,9th and 12th months	To assess the coping resources to manage stress available to an individual.
Client Satisfaction Questionnaire (CSQ).	Baseline,3rd,6th,9th and 12th months	The participants will rate their satisfaction with treatment by using the CSQ.
EuroQol-5 Dimensions (EQ5-D)	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).

Trial Locations

Locations (7)

Bolan Medical Complex; 🇵🇰 Quetta, Balochistan, Pakistan

Khyber Teaching Hospital; 🇵🇰 Peshawar, KPK, Pakistan

Rawalpindi General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan

Jinah Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Services Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Civil Hospital; 🇵🇰 Karachi, Sind, Pakistan

Abbasi Hospital; 🇵🇰 Karachi, Sindh, Pakistan