Clinical trial NCT02742922: Multicenter Study to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Harm
Keywords: self harm
culturally adapted therapy
problem solving therapy
low and middle income countries
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Dow University of Health Sciences
name: Karachi Medical and Dental College
name: Services Hospital, Lahore
name: Peshawar Medical College
First posted: 2016-04-19
Enrollment: 901
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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.

Primary outcomes:
measure: Suicide Attempt Self Injury Interview SASII
timeFrame: up to 12th months
Secondary outcomes:
measure: Beck Scale for Suicidal ideation (BSI).
timeFrame: Baseline, 3, 6, 9 and 12th months
measure: Beck Hopelessness Scale
timeFrame: Baseline,3rd,6th,9th and 12th months
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline,3rd,6th,9th and 12th months
measure: EuroQol-5 Dimensions (EQ5-D)
timeFrame: Baseline,3rd,6th,9th and 12th months
measure: Coping Resource Inventory (CRI).
timeFrame: Baseline,3rd,6th,9th and 12th months
measure: Client Satisfaction Questionnaire (CSQ).
timeFrame: Baseline,3rd,6th,9th and 12th months
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Bolan Medical Complex
state: Balochistan
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: KPK
city: Lahore
country: Pakistan
facility: Jinah Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Rawalpindi General Hospital
state: Punjab
city: Karachi
country: Pakistan
facility: Abbasi Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Civil Hospital
state: Sind
Study officials:
affiliation: University of Manchester
name: Nusrat Husian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.