ECMAP: Culturally Adapted Suicide Prevention Intervention for Older Adults

Sponsor

Pakistan Institute of Living and Learning (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06019650

Collaborator

(none)

192

Enrollment

Location

Arms

21.9

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation	Behavioral: ECMAP	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention C-MAP 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.
No Intervention: Standard Routine Care Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources

Arm

Intervention/Treatment

Experimental: Intervention

C-MAP 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.

No Intervention: Standard Routine Care

Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources

Outcome Measures

Primary Outcome Measures

Suicidal Ideation [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 severeity of suicidal ideation (BSI) (Beck & Steer, 1991)

Secondary Outcome Measures

Hopelessness [change in total scores from baseline to 3-month post randomization assessment]
Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale (BHS) (Beck & Steer, 1988). Higher scores indicate greater severity of hopelessness.
Depression [change in total scores from baseline to 3-month post randomization assessment]
Participants severity of depression will be assessed using the Beck Depression Inventory (BDI) (Beck, Ward, & Mendelson, 1961). Higher scores indicate greater severity of depression.
Health-related Quality of Life [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 (Herdman et al., 2011). Higher scores indicate better health related quality of life
Coping Resource Inventory [change in total scores from baseline to 3-month post randomization assessment]
Participants coping skills will be assessed using the Coping Resource Inventory (CRI) (Martin & Hammer, 1988). Higher scored indicate better coping skills.
Client Satisfaction Questionaire [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 (CSQ) (Attkisson & Zwick, 1982). Higher scores indicate greater level of satisfaction with the services.
Service Usage [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 (CSRI) (Beecham & Knapp, 2001)
Episodes of Self-harm [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 (SASII) (Linehan, Comtois, Brown, Heard, & Wagner, 2006). This is the semi-structured instrument to assess diffeent aspects of episode of self-harm
Problem Solving Skills [change in total scores from baseline to 3-month post randomization assessment]
Participants problem Solving skills will be assessed using Problem solving Inventory (PSI) (Heppner & Petersen, 1982). Higher scores indicate better problem solving skills.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.