Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-based Interventions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Geneva, Switzerland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Aged below 65.
Inability to use and lack of access to a digital device required for using the digital training platform.
Trial design
Design model
Parallel
Treatments tested in this trial
Stress management training
BehavioralThe 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.
Multidomain cognitive training
BehavioralThe 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.
Social activities
BehavioralThe 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.
Treatment groups
1,000 Participants
are divided into 4 treatment groupsGroup A: Stress management training Self-Help+ (SH+)Experimental treatment 1 intervention
Group B: Multodomain cognitive training (COG)Experimental treatment 1 intervention
Group C: SH+ and COG combinedExperimental treatment 2 interventions
Group D: Podcast discussionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
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).
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.3
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.
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.4
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.
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 outcomes
1
Perceived health
Measurement tool: EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L; Herdman et al., 2011); Unit of measure: Visual Analog Scale (VAS; range: 0-100). Higher values on the VAS indicate better 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.Other outcomes
1
Overall cognitive functioning
Measurement tool: Cognitive Telephone Screening Instrument, Scale (COGTEL, online version: E-COGTEL; Kliegel et al., 2007); Unit of measure: The total COGTEL score is derived from the sum of the weighted scores of each of the six subtests. A high score indicates better global cognitive functioning.
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.2
Abstract reasoning and fluid intelligence
Measurement tool: Raven Advanced Progressive Matrices - Short Form, Scale (APM; Arthur \& Day, 1994; Raven et al., 1985); Unit of measure: The APM total score ranges from 0 to 12 points, with higher scores indicating a higher general cognitive ability.
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.3
Subjective cognitive complaints
Measurement tool: Subjective Cognitive Complaints Questionnaire (self-designed; Geerlings et al., 1999; Jessen, 2010; EIlis et al., 2014); Unit of measure: This instrument consists of five yes/no items that assess both perceived memory decline and related concerns.
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.4
Perceived age discrimination
Measurement tool: Perceived Experiences of Age Discrimination Scale (PAD; De Paula Couto et al., 2023); Unit of measure: The PAD total score ranges from 0 to 4, with higher scores indicating a greater frequency or intensity of perceived age discrimination.
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.Sponsors and contacts
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Source ClinicalTrials.gov
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