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

University of Geneva, Switzerland

Status: Not yet enrolling

Conditions: Ageing; Cognition; Well-Being, Psychological

Treatments: Behavioral: Stress management training; Behavioral: Multidomain cognitive training; Behavioral: Social activities

Study type: Interventional

Funder types: Other

Identifiers

NCT07072338

101080323

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 4 patient groups

Stress management training Self-Help+ (SH+)

Experimental group

Treatment:

Behavioral: Stress management training

Multodomain cognitive training (COG)

Experimental group

Treatment:

Behavioral: Multidomain cognitive training

SH+ and COG combined

Experimental group

Treatment:

Behavioral: Multidomain cognitive training

Behavioral: Stress management training

Podcast discussions

Active Comparator group

Treatment:

Behavioral: Social activities