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

NCT07072338 | Not Yet Recruiting DMC

• 1 other identifier: 101080323
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Well-Being, Psychological; Cognition; Ageing

Keywords

well-being; mental health; cognitive health; healthy aging; cognitive function; stress-management training; Acceptance and commitment therapy; cognitive training; lifrstyle intervention

Outcome Measures

Primary Outcomes (7)

• Health related quality of life

  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.

  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

  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).

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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) and Visual Analog Scale (VAS; range: 0-100). Higher values on the EQ-5D index indicate better health status, and higher values on the VAS also indicate better 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.

Secondary Outcomes (1)

• 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.

Other Outcomes (15)

• Overall cognitive functioning

  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.

• Abstract reasoning and fluid intelligence

  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.

• Subjective cognitive complaints

  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.

Study Arms (4)

Stress management training Self-Help+ (SH+)

EXPERIMENTAL

Behavioral: Stress management training

Multodomain cognitive training (COG)

EXPERIMENTAL

Behavioral: Multidomain cognitive training

SH+ and COG combined

EXPERIMENTAL

Behavioral: Stress management training; Behavioral: Multidomain cognitive training

Podcast discussions

ACTIVE COMPARATOR

Behavioral: Social activities

Interventions

Stress management training BEHAVIORAL

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.

SH+ and COG combined; Stress management training Self-Help+ (SH+)

Multidomain cognitive training BEHAVIORAL

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 participants sustainably integrate these behaviors into their daily lives. The program is delivered over five sessions and supported by a digital platform for at-home practice.

Multodomain cognitive training (COG); SH+ and COG combined

Social activities BEHAVIORAL

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 functioning in the SH+ or COG interventions. The program is delivered over five sessions.

Podcast discussions

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

Center for the Interdisciplinary Study of Gerontology and Vulnerabilities

Geneva, Canton of Geneva, 1227, Switzerland

Location

Related Links

• Project website
• Information for participants

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Matthias Kliegel, Professor

CONTACT

+41 22 379 9176; matthias.kliegel@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher at the Center for the Interdisciplinary Study of Gerontology and Vulnerabilities (CIGEV), University of Geneva, under the supervision of Professor Matthias Kliegel

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)