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Culturally Adapted Suicide Prevention Intervention for Older Adults

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019650
Acronym
ECMAP
Enrollment
192
Registered
2023-08-31
Start date
2023-11-01
Completion date
2025-06-30
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation

Keywords

suicidal ideation,, self-harm, older adult, elderly, ECMAP, Pakistan, LMIC

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.

Interventions

BEHAVIORALECMAP

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.

Sponsors

Pakistan Institute of Living and Learning
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Suicidal Ideationchange in total scores from baseline to 3-month post randomization assessmentParticipants 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

MeasureTime frameDescription
Depressionchange in total scores from baseline to 3-month post randomization assessmentParticipants 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.
Health-related Quality of Lifechange in total scores from baseline to 3-month post randomization assessmentParticipants Health related quality of life will be assessed using the EQ-5D- 5L. Higher scores indicate better health related quality of life
Coping Resource Inventorychange in total scores from baseline to 3-month post randomization assessmentParticipants coping skills will be assessed using the Coping Resource Inventory. Higher scored indicate better coping skills.
Hopelessnesschange in total scores from baseline to 3-month post randomization assessmentParticipants 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
Service Usagechange in total scores from baseline to 3-month post randomization assessmentService 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.
Episodes of Self-harmchange in total scores from baseline to 3-month post randomization assessmentEpisodes 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.
Problem Solving Skillschange in total scores from baseline to 3-month post randomization assessmentParticipants 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.
Client Satisfaction Questionairelevel of satisfaction at end of intervention i.e., 3-month post-randomizationParticipant satisfaction with services will be assessed using the Client Satisfaction Questionnaire. Higher scores indicate greater level of satisfaction with the services.

Countries

Pakistan

Contacts

Primary ContactTayyeba Kiran, PhD
tayyaba.kiran@pill.org.pk02135871845
Backup ContactSehrish Tofique, PhD fellow
sehrish.tofique@pill.org.pk02135871845

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026