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

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

Study Overview

• Status: Completed
• Conditions: Self Harm
• Intervention / Treatment: Behavioral: Culturally adapted therapy (C-MAP)

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 Type: Interventional
• Enrollment (Actual): 901
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Balochistan
    • Quetta, Balochistan, Pakistan
      • Bolan Medical Complex
  • KPK
    • Peshawar, KPK, Pakistan
      • Khyber Teaching Hospital
  • Punjab
    • Lahore, Punjab, Pakistan
      • Services Hospital
    • Lahore, Punjab, Pakistan
      • Jinah Hospital
    • Rawalpindi, Punjab, Pakistan
      • Rawalpindi General Hospital
  • Sind
    • Karachi, Sind, Pakistan, 72400
      • Civil Hospital
  • Sindh
    • Karachi, Sindh, Pakistan
      • Abbasi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Collaborators: University of Manchester; Dow University of Health Sciences; Services Hospital, Lahore; Peshawar Medical College; Karachi Medical and Dental College
• Investigators: Principal Investigator: Nusrat Husian, MD, University of Manchester

Publications and helpful links

General Publications

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

Helpful Links

• Pakistan Institute of Learning and Living

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2016
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: self harm; low and middle income countries; culturally adapted therapy; problem solving therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: PILL-CMAP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED