Culturally Adapted Suicide Prevention Intervention for Older Adults

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

Detailed Description
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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.

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

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Behavioral: ECMAP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Standard Routine Care<br>Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation | 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) | change in total scores from baseline to 3-month post randomization assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopelessness | Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale (BHS) (Beck & Steer, 1988). Higher scores indicate greater severity of hopelessness. | change in total scores from baseline to 3-month post randomization assessment | 
| Depression | Participants severity of depression will be assessed using the Beck Depression Inventory (BDI) (Beck, Ward, & Mendelson, 1961). Higher scores indicate greater severity of depression. | change in total scores from baseline to 3-month post randomization assessment | 
| Health-related Quality of Life | 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 | change in total scores from baseline to 3-month post randomization assessment | 
| Coping Resource Inventory | Participants coping skills will be assessed using the Coping Resource Inventory (CRI) (Martin & Hammer, 1988). Higher scored indicate better coping skills. | change in total scores from baseline to 3-month post randomization assessment | 
| Client Satisfaction Questionaire | 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. | level of satisfaction at end of intervention i.e., 3-month post-randomization | 
| Service Usage | 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) | change in total scores from baseline to 3-month post randomization assessment | 
| Episodes of Self-harm | 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 | change in total scores from baseline to 3-month post randomization assessment | 
| Problem Solving Skills | Participants problem Solving skills will be assessed using Problem solving Inventory (PSI) (Heppner & Petersen, 1982). Higher scores indicate better problem solving skills. | change in total scores from baseline to 3-month post randomization assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suicidal ideation,, self-harm, older adult, elderly, ECMAP, Pakistan, LMIC