Recruiting

Positive Psychology for Early-stage Cognitive Decline in Dementia

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What is being tested

Positive Psychology Intervention

+ Treatment as usual (TAU)

Behavioral
Who is being recruted

Alzheimer Disease+8

+ Mental Disorders

+ Brain Diseases

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorAristotle University Of Thessaloniki
Study ContactDimitra Vasileiou, M.Sc., PhD candidate
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 17, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on exploring how Positive Psychology Interventions (PPIs) could help older adults experiencing early-stage cognitive decline related to dementia, such as Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI). Dementia currently affects millions worldwide, and there is no cure, making it crucial to find safe and practical ways to slow down the decline and maintain brain function. PPIs aim to enhance mental well-being and cognitive performance by promoting positive traits and lifestyles. This study tests an online program that is easy to follow and aims to improve cognitive abilities and brain activity in people with early cognitive challenges. By proving the effectiveness of this program, the research could offer a new, low-risk approach that complements usual care and potentially slows the progression of these conditions. Participants in the study will join small group sessions led by trained psychologists through video calls once a week for 16 weeks. The study will measure changes in participants’ cognitive abilities and brain function before the program starts, midway through, at the end of the program, and nine months later. These evaluations include cognitive tests and brain activity assessments using methods like EEG and fNIRS. The study will also track participants' well-being and the practicality of this online approach. The trial is designed to be safe, with minimal risks, and includes measures to ensure participants' comfort. By demonstrating the program's benefits, the study hopes to provide evidence for PPIs as a valuable tool for improving the lives of those with early cognitive decline.

Official TitleApplication of Positive Psychology Interventions in Individuals With Early-stage Cognitive Decline Related to Dementia: Their Impact on Cognitive and Brain Functioning
NCT07289061
Principal SponsorAristotle University Of Thessaloniki
Study ContactDimitra Vasileiou, M.Sc., PhD candidate
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

1 inclusion criteria required to participate
Documented diagnosis of Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) according to clinical evaluation and site standard criteria.
5 exclusion criteria prevent from participating
Diagnosis of dementia (major neurocognitive disorder) or other major neurocognitive disorder that is moderate or severe.
Major psychiatric disorder currently unstable or untreated (e.g., major depression with psychotic features, bipolar disorder, schizophrenia).
Neurological conditions that affect cognition.
Uncorrected hearing or vision problems that prevent participation in assessments or online sessions.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Multi-component Positive Psychology Intervention delivered online in small groups. One session per week (\~60 minutes) for about 16 weeks plus brief daily home practice (about 10 minutes). Core components include identifying and using character strengths and mindfulness. Facilitated by trained psychologist. No medicines are given.

Group II

Active Comparator
Participants continue the treatment they already receive (e.g. cognitive training) from their usual providers. No additional structured positive psychology program is delivered by the study team. Assessments occur at the same time points as the experimental arm (baseline, mid-program, post-program, and follow-up).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Aristotle University of Thessaloniki

Thessaloniki, GreeceOpen Aristotle University of Thessaloniki in Google Maps
Recruiting
One Study Center