Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-based Interventions

Официальное название

PROMISE: Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-Based Interventions - Study Protocol for a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое Stress management training
  The stress management training is the WHO SH+ (Self-Help Plus) program, a low-intensity, group-based intervention developed by the World Health Organization to improve stress management and psychological flexibility. It combines pre-recorded audio sessions with an illustrated self-help guide and is based on Acceptance and Commitment Therapy (ACT). The program is delivered over five sessions and supported by a digital platform for at-home practice.
• Поведенческое Multidomain cognitive training
  The multidomain cognitive training is a low-intensity, group-based intervention aimed at sustainably improving a healthy lifestyle, which in turn supports brain health and cognitive functioning. It combines pre-recorded audio sessions with an illustrated self-help guide and provides knowledge about aging and how to enhance three key lifestyle factors-social engagement, physical activity, and cognitive stimulation. The training uses metacognitive strategies and monitoring tools to help participan
• Поведенческое Social activities
  The social activity intervention consists of a podcast discussion group in which participants listen to short podcasts on aging-related topics during each group session. Topics include driving (Session 1), intergenerational relationships (Session 2), technology (Session 3), the transition to retirement (Session 4), and travel (Session 5). These themes are deliberately chosen to be neutral and are not directly related to the techniques or content used to enhance well-being or cognitive functionin

Первичные конечные точки

• Health related quality of life [Срок оценки: 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.]
• Well-being [Срок оценки: 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.]
• Psychological distress [Срок оценки: 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.]
• Depression [Срок оценки: 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.]
• Anxiety [Срок оценки: 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.]
• Cognitive health [Срок оценки: 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.]
• Health related quality of life [Срок оценки: 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.]

Вторичные конечные точки (1)

• Perceived health [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Aged below 65.
• Inability to use and lack of access to a digital device required for using the digital training platform.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• Center for the Interdisciplinary Study of Gerontology and Vulnerabilities — Geneva

Идентификаторы

NCT: NCT07072338 · 101080323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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