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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 May 2023
• Main ID: NCT02742922
• Date of registration: 19/02/2016
• Prospective Registration: Yes
• Primary sponsor: Pakistan Institute of Living and Learning
• Public title: Multicenter Study to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) C-MAP
• Scientific 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
• Date of first enrolment: April 27, 2016
• Target sample size: 901
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02742922
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Pakistan

Contacts

• Name: Nusrat Husian, MD
• Affiliation: University of Manchester

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Self Harm

Intervention(s)

Behavioral: Culturally adapted therapy (C-MAP)

Primary Outcome(s)

Suicide Attempt Self Injury Interview SASII [Time Frame: up to 12th months]

Secondary Outcome(s)

Beck Depression Inventory (BDI) [Time Frame: Baseline,3rd,6th,9th and 12th months]

Beck Scale for Suicidal ideation (BSI). [Time Frame: Baseline, 3, 6, 9 and 12th months]

EuroQol-5 Dimensions (EQ5-D) [Time Frame: Baseline,3rd,6th,9th and 12th months]

Beck Hopelessness Scale [Time Frame: Baseline,3rd,6th,9th and 12th months]

Coping Resource Inventory (CRI). [Time Frame: Baseline,3rd,6th,9th and 12th months]

Client Satisfaction Questionnaire (CSQ). [Time Frame: Baseline,3rd,6th,9th and 12th months]

Secondary ID(s)

PILL-CMAP-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Karachi Medical and Dental College

Services Hospital, Lahore

University of Manchester

Dow University of Health Sciences

Peshawar Medical College