PROMISE: Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-Based Interventions - Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
Mental and cognitive health are key determinants of healthy and successful aging. These two domains are closely intertwined: while chronic stress can impair cognitive functioning, cognitive decline may in turn heighten stress and reduce overall well-being in older adults. This project aims to evaluate the effectiveness and scalability of a multidomain intervention to support mental and cognitive health in older adults. A single-blind, randomized, controlled 2×2 factorial trial will be conducted with a large sample of community-dwelling adults aged 65 years and older in the German- and French-speaking regions of Switzerland. Participants will be randomly assigned to one of four intervention arms: (1) WHO Self-Help Plus stress management training (SH+), (2) multidomain cognitive training focused on lifestyle and behavior change (COG), (3) a combined SH+ and COG intervention (SH+/COG), or (4) an active control group (CG) involving podcast listening and discussion. All interventions will include in-person group sessions, while the SH+, COG, and SH+/COG arms additionally offer a digital platform for self-guided home training. Primary outcomes (mental and cognitive health), secondary outcomes and moderators (cognitive functioning, stigma, self-efficacy, self-concept, loneliness, digital literacy, cognitive reserve, sociodemographic variables) will be assessed at baseline, post-intervention (10 weeks), and at 2- and 6-month follow-ups through a self-administered ambulatory assessment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 years or older.
- •Ability to speak and read the official language of their place of residence (French or German).
- •Ability to use and access a digital device for a digital training platform provided for the training.
排除标准
- •Aged below
- •Inability to use and lack of access to a digital device required for using the digital training platform.
结局指标
主要结局
Health related quality of life
时间窗: Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Measurement tool: EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L; Herdman et al., 2011); Unit of measure: EQ-5D-5L index score (country-specific value set; range: -0.661 to 1.000 for Germany). Higher values on the EQ-5D index indicate better health status.
Psychological distress
时间窗: Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Measurement tool: Kessler Psychological Distress Scale (K6; Kessler et al., 2002); Unit of measure: K6 total score ranges from 0 to 24, with higher values indicating greater psychological distress.
Depression
时间窗: Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Measurement tool: Geriatric Depression Scale - Short Form, Scale (GDS-SF; Sheikh \& Yesavage, 1986); Unit of measure: GDS-SF total score ranges from 0 to 15, with higher scores indicating higher levels of depression.
Anxiety
时间窗: Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Measurement tool: Geriatric Anxiety Inventory - Short Form, Scale (GAI-SF; Byrne \& Pachana, 2010); Unit of measure: The GAI-SF total score ranges between 0 to 5, with higher scores representing higher anxiety levels.
Well-being
时间窗: Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Measurement tool: Capability Index for Older People, Scale (ICECAP-O; Gustafsson \& Horder, 2022; Coast et al., 2008); Unit of measure: The ICECAP-O assesses five core dimensions of well-being relevant to older adults (attachment, security, role, enjoyment, control). ICECAP-O scores on the five core dimensions range from 1 to 4, with 1 being the lowest and 4 being the highest. These raw scores are then converted to tariff scores, ranging from 0 (representing absence of capability) to 1 (representing full capability).
Cognitive health
时间窗: Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Measurement tool: Brain Care Score, Scale (self-designed scale based on Singh et al., 2023; Livingston et al., 2020; Ngandu et al., 2015); The Brain Care Score assesses six key dimensions known to be related to brain health: exercise, cognitive stimulation, social engagement, stress, sleep, and nutrition. Scores on the six dimensions range from 1 to 5. The total score ranges from 6 to 30, with higher scores indicating a lifestyle more supportive of brain health.
次要结局
- Perceived health(Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.)
研究者
Melanie Mack
Postdoctoral researcher at the Center for the Interdisciplinary Study of Gerontology and Vulnerabilities (CIGEV), University of Geneva, under the supervision of Professor Matthias Kliegel
University of Geneva, Switzerland