Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-based Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stress management training, Multidomain cognitive training, Social activities.
- Who it may be relevant to
- Registry conditions: Well-Being, Psychological, Cognition, Ageing. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PROMISE: Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-Based Interventions - Study Protocol for a Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral 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. - Behavioral 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 - Behavioral 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
Primary outcome measures
- Health related quality of life [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
Secondary outcome measures (1)
- Perceived health [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Aged below 65.
- Inability to use and lack of access to a digital device required for using the digital training platform.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Switzerland · 1 center
- Center for the Interdisciplinary Study of Gerontology and Vulnerabilities — Geneva
Identifiers
NCT: NCT07072338 · 101080323