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

Primary Purpose

Self Harm

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Culturally adapted therapy (C-MAP)
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Self Harm focused on measuring self harm, culturally adapted therapy, problem solving therapy, low and middle income countries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bolan Medical Complex
  • Khyber Teaching Hospital
  • Jinah Hospital
  • Services Hospital
  • Rawalpindi General Hospital
  • Abbasi Hospital
  • Civil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Culturally adapted therapy (C-MAP)

Treatment as usual

Arm Description

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

This arm will receive no intervention only TAٓU.

Outcomes

Primary Outcome Measures

Suicide Attempt Self Injury Interview SASII
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)

Secondary Outcome Measures

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.
Beck Hopelessness Scale
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression
Beck Depression Inventory (BDI)
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression
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).
Coping Resource Inventory (CRI).
To assess the coping resources to manage stress available to an individual.
Client Satisfaction Questionnaire (CSQ).
The participants will rate their satisfaction with treatment by using the CSQ.

Full Information

First Posted
February 19, 2016
Last Updated
May 18, 2023
Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Karachi Medical and Dental College, Services Hospital, Lahore, Peshawar Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02742922
Brief Title
Multicenter Study to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP)
Acronym
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester, Dow University of Health Sciences, Karachi Medical and Dental College, Services Hospital, Lahore, Peshawar Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Harm
Keywords
self harm, culturally adapted therapy, problem solving therapy, low and middle income countries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturally adapted therapy (C-MAP)
Arm Type
Experimental
Arm Description
Culturally adapted manual assisted (C-MAP) brief problem solving therapy
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
This arm will receive no intervention only TAٓU.
Intervention Type
Behavioral
Intervention Name(s)
Culturally adapted therapy (C-MAP)
Other Intervention Name(s)
psycho social intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide Attempt Self Injury Interview SASII
Description
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)
Time Frame
up to 12th months
Secondary Outcome Measure Information:
Title
Beck Scale for Suicidal ideation (BSI).
Description
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.
Time Frame
Baseline, 3, 6, 9 and 12th months
Title
Beck Hopelessness Scale
Description
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression
Time Frame
Baseline,3rd,6th,9th and 12th months
Title
Beck Depression Inventory (BDI)
Description
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression
Time Frame
Baseline,3rd,6th,9th and 12th months
Title
EuroQol-5 Dimensions (EQ5-D)
Description
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).
Time Frame
Baseline,3rd,6th,9th and 12th months
Title
Coping Resource Inventory (CRI).
Description
To assess the coping resources to manage stress available to an individual.
Time Frame
Baseline,3rd,6th,9th and 12th months
Title
Client Satisfaction Questionnaire (CSQ).
Description
The participants will rate their satisfaction with treatment by using the CSQ.
Time Frame
Baseline,3rd,6th,9th and 12th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 years will be considered eligible for the study. Participants will have to be living within the catchment area of the participating practices and hospitals. Not needing inpatient psychiatric treatment. Exclusion Criteria: Temporary resident unlikely to be available for follow up. 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. Unable to engage, participate or respond to the research questionnaires.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nusrat Husian, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolan Medical Complex
City
Quetta
State/Province
Balochistan
Country
Pakistan
Facility Name
Khyber Teaching Hospital
City
Peshawar
State/Province
KPK
Country
Pakistan
Facility Name
Jinah Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Rawalpindi General Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Facility Name
Abbasi Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Civil Hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
72400
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33884617
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.
Results Reference
derived
Links:
URL
http://pill.org.pk
Description
Pakistan Institute of Learning and Living

Learn more about this trial

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

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