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Clinical Trials/NCT06019650
NCT06019650
Recruiting
Not Applicable

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

Pakistan Institute of Living and Learning1 site in 1 country192 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
Pakistan Institute of Living and Learning
Enrollment
192
Locations
1
Primary Endpoint
Suicidal Ideation
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Hopelessness(change in total scores from baseline to 3-month post randomization assessment)
  • Depression(change in total scores from baseline to 3-month post randomization assessment)
  • Health-related Quality of Life(change in total scores from baseline to 3-month post randomization assessment)
  • Coping Resource Inventory(change in total scores from baseline to 3-month post randomization assessment)
  • Client Satisfaction Questionaire(level of satisfaction at end of intervention i.e., 3-month post-randomization)
  • Service Usage(change in total scores from baseline to 3-month post randomization assessment)
  • Episodes of Self-harm(change in total scores from baseline to 3-month post randomization assessment)
  • Problem Solving Skills(change in total scores from baseline to 3-month post randomization assessment)

Study Sites (1)

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