Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-27 @ 2:36 AM
Study NCT ID:
NCT06019650
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Suicide Prevention Intervention for Older Adults
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECMAP
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: