Elderly Culturally Adapted Manual Assisted Brief Psychological Therapy (E-CMAP) for Older Adults With Suicidal Ideation: An Exploratory Randomized Controlled Trial From Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Suicidal Ideation
研究概览
简要总结
determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (E-CMAP) with suicidal ideation
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Unable to provide consent due to severe mental or physical illness.
- •Unlikely to be available for outcome assessments (temporary residence)
结局指标
主要结局
Suicidal Ideation
时间窗: 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.
次要结局
- 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)