Culturally Adapted Suicide Prevention Intervention for Older Adults (ECMAP)

May 16, 2024 updated by: Pakistan Institute of Living and Learning

Elderly Culturally Adapted Manual Assisted Brief Psychological Therapy (E-CMAP) for Older Adults With Suicidal Ideation: An Exploratory Randomized Controlled Trial From Pakistan

determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (E-CMAP) with suicidal ideation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Suicide is a serious public health concern. Each year more than 800,000 people worldwide die due to suicide. Most of these (79%) are in the low and middle-income countries (LMIC), with an increased risk of suicide in ageing.

Primary Objective: To assess the effectiveness of E-CMAP compared to Treatment as Usual (TAU) as measured by reduction in suicidal ideation third month post-randomization with Beck Scale for Suicidal ideation (BSI) (Beck & Steer, 1991) Secondary outcomes: the two groups will be compared on hopelessness, depression, quality of life, coping skills, participant satisfaction, health/social care usage, and episodes of self-harm. All variables known to be related to suicide risk.

The study will be carried out in two stages. First stage will be cultural adaptation and refinement of the intervention and second stage will be feasibility Randomised Control Trial (RCT).

Stage 1: In the first stage, the adaptation of the intervention for suicidal ideation in older adults will be carried out by a group of experts including a master trainer, a bilingual health expert, mental health professional potential user (i.e., older adults with suicidal ideation), and a senior therapist through discussion groups.

Stage 2: Feasibility randomized controlled trial (RCT) After adaptation, the intervention will be tested in a multicenter RCT to determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults/elderly (E-CMAP) with suicidal ideation.

Study Type

Interventional

Enrollment (Estimated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

In the context of this study, suicidal ideation is defined as; "Passive thoughts about wanting to be dead or active thoughts about killing oneself, these thoughts may include plan but not accompanied by preparatory behavior" (Griffin et al., 2020)

  • 50 years and above
  • Has recent history of experiencing suicidal ideation
  • Participants living within the catchment area of the participating practices and hospitals.
  • Capacity to give informed consent.

Exclusion Criteria:

  • Unable to provide consent due to severe mental or physical illness.
  • Unlikely to be available for outcome assessments (temporary residence)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Routine Care
Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources
Experimental: E-CMAP Intervention
CMAP is a culturally adapted brief problem-focused therapy, based on the principles of CBT which has been adapted with permission from a self-help guide called "Life after self-harm"(Schmidt & Davidson, 2004). This intervention includes evaluation of the self-harm attempt, crisis skills, problem-solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.
Behavioral: ECMAP
The therapist will deliver 12-week training program comprised of 6 sessions at the participant's home/outpatient clinic depending upon the participants' choice within 3 months. The first two sessions will be offered weekly and then fortnightly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal Ideation
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Participants suicidal ideation will be assessed using the Beck scale for suicidal ideation. Higher scores on the questionnaire indicate greater severity of suicidal ideation. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe.
change in total scores from baseline to 3-month post randomization assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopelessness
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale. Higher scores indicate greater severity of hopelessness. Scores ranging from: 0 to 3 as are considered within the normal range, 4 to 8 identify mild hopelessness, scores from 9 to 14 identify moderate hopelessness, and scores greater than 14 identify severe hopelessness
change in total scores from baseline to 3-month post randomization assessment
Depression
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Participants severity of depression will be assessed using the Beck Depression Inventory. Higher scores indicate greater severity of depression. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
change in total scores from baseline to 3-month post randomization assessment
Health-related Quality of Life
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Participants Health related quality of life will be assessed using the EQ-5D- 5L. Higher scores indicate better health related quality of life
change in total scores from baseline to 3-month post randomization assessment
Coping Resource Inventory
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Participants coping skills will be assessed using the Coping Resource Inventory. Higher scored indicate better coping skills.
change in total scores from baseline to 3-month post randomization assessment
Client Satisfaction Questionaire
Time Frame: level of satisfaction at end of intervention i.e., 3-month post-randomization
Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire. Higher scores indicate greater level of satisfaction with the services.
level of satisfaction at end of intervention i.e., 3-month post-randomization
Service Usage
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Service usage (including formal (GPs/ other doctor and informal sector such as faith healers/imams) will be assessed using client service receipt inventory. There are no score ranges for this scale.
change in total scores from baseline to 3-month post randomization assessment
Episodes of Self-harm
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Episodes of Self-harm will be assessed using the Suicide attempt self -injury interview. This is the semi-structured instrument to assess different aspects of episode of self-harm. This scale does not have any cut-off or score ranges.
change in total scores from baseline to 3-month post randomization assessment
Problem Solving Skills
Time Frame: change in total scores from baseline to 3-month post randomization assessment
Participants problem Solving skills will be assessed using Problem solving Inventory. Higher scores indicate better problem solving skills. The possible total scale score of PSI ranges between 32 and 192.
change in total scores from baseline to 3-month post randomization assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECMAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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