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

Self Harm Clinical Trial

— C-MAP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742922
• Other study ID #: PILL-CMAP-001
• Status: Completed
• Phase: N/A
• Start date: April 27, 2016
• Est. completion date: October 30, 2019

Study information

• Verified date: May 2023
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: October 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self Harm
• Self-Injurious Behavior

Intervention

Behavioral:
• Culturally 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.

Locations

Country	Name	City	State
Pakistan	Abbasi Hospital	Karachi	Sindh
Pakistan	Civil Hospital	Karachi	Sind
Pakistan	Jinah Hospital	Lahore	Punjab
Pakistan	Services Hospital	Lahore	Punjab
Pakistan	Khyber Teaching Hospital	Peshawar	KPK
Pakistan	Bolan Medical Complex	Quetta	Balochistan
Pakistan	Rawalpindi General Hospital	Rawalpindi	Punjab

Sponsors (6)

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

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Coping Resource Inventory (CRI).	To assess the coping resources to manage stress available to an individual.	Baseline,3rd,6th,9th and 12th months
Secondary	Client Satisfaction Questionnaire (CSQ).	The participants will rate their satisfaction with treatment by using the CSQ.	Baseline,3rd,6th,9th and 12th months

External Links

•   Pakistan Institute of Learning and Living