Positive Psychology for Early Cognitive Decline: Effects on Cognitive and Brain Function

NCT07289061 | Recruiting

• 1 other identifier: 99/5-6-2024
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized study tests whether a new multicomponent Positive Psychology program can improve cognition and wellbeing in older adults at the earliest stages of dementia-related decline. About 128 participants with Subjective Cognitive Decline or Mild Cognitive Impairment will be enrolled. Half will be randomized to the Positive Psychology program and half to Treatment As Usual (TAU). The program consists of weekly, small-group online sessions for \~24 weeks plus brief home practices. All participants (both arms) will complete questionnaires and cognitive tests at baseline, during treatment, post-treatment, and 9-month follow-up. Primary question: Do participants receiving the Positive Psychology program show better cognitive and brain-function outcomes than TAU at post-treatment and at 9 months? Secondary question: Are effects larger for SCD than MCI? No medicines are used and risks are minimal. If effective, this scalable, low-cost, non-pharmacological approach could complement usual care for people in very early cognitive decline.

Conditions

Subjective Cognitive Decline (SCD); Mild Cognitive Impairment (MCI); Alzheimer Dementia (AD)

Keywords

positive psychology; non-pharmacological intervention for dementia; character strengths; mindfulness; forgiveness; gratitude; humor; alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• Global cognitive composite (z-score) from REMEDES4Alzheimer

  Composite derived from REMEDES4Alzheimer subtests covering episodic memory, working memory, attention subdomains, and executive functions. Raw scores are standardized to z using baseline means,SDs and averaged to a global composite (higher scores indicate better cognition). Unit of measure: z-score (higher = better)

  T0: Baseline prior to randomization T1: Mid-intervention at 6 weeks T2: Post-intervention at 16 weeks (primary endpoint) T3: Nine-month follow-up after T2

• Resting-state fNIRS functional connectivity (HbO) between bilateral dorsolateral prefrontal cortices

  Resting-state fNIRS recorded for 5-8 minutes (eyes-open fixation). Oxygenated hemoglobin (HbO) signals are preprocessed with motion-artifact correction, short-channel regression (if available), and band-pass filtering (e.g., 0.01-0.1 Hz). Functional connectivity is computed as the Pearson correlation between left and right DLPFC regions of interest and converted to Fisher z for analysis.

  T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2) Unit of measure: Fisher z-transformed correlation coefficient (higher = stronger connectivity)

• EEG alpha power at rest (eyes-closed)

  Mean absolute power in the 8-12 Hz band during 3-min resting eyes-closed, averaged across parieto-occipital electrodes; processed with artifact rejection and ICA according to prespecified pipeline. μV² (higher = better/according to hypothesis)

  Time Frame: T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2)

Secondary Outcomes (4)

• Character Strengths total score (VIA-114GR)

  T0: Baseline prior to randomization T1: Mid-intervention at 6 weeks T2: Post-intervention at 16 weeks (primary endpoint) T3: Nine-month follow-up after T2

• Wellbeing - PERMA-Profiler total score

  T0: Baseline prior to randomization T1: Mid-intervention at 6 weeks T2: Post-intervention at 16 weeks (primary endpoint) T3: Nine-month follow-up after T2

• Mindfulness (MAAS total)

  T0: Baseline prior to randomization T1: Mid-intervention at 6 weeks T2: Post-intervention at 16 weeks (primary endpoint) T3: Nine-month follow-up after T2

• Positive Affect (PANAS)

  T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2)

Study Arms (2)

Positive Psychology Intervention

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.

Behavioral: Positive Psychology Intervention

Treatment as Usual

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).

Behavioral: Treatment as usual (TAU)

Interventions

Positive Psychology Intervention BEHAVIORAL

Online, group-based Positive Psychology intervention delivered by trained psychologist. One 60-minute session per week for \~16 weeks plus brief daily home practice (\~10 minutes). Core components: identification and use of character strengths and mindfulness practices. Includes goal setting and habit formation. Materials provided in Greek. The sessions will take place via secure videoconference. No medications are administered. Participants will continue to receive TAU but they will have one extra hour per week for Positive Psychology Intervention.

Positive Psychology Intervention

Treatment as usual (TAU) BEHAVIORAL

Structured cognitive training program targeting attention, memory, and executive functions. Participants will continue to receive cognitive training at Alzheimer Hellas. Activities include paper-and-pencil and computerized tasks (e.g., working-memory, processing speed, problem solving). No Positive Psychology components are included.

Treatment as Usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) according to clinical evaluation and site standard criteria.

You may not qualify if:

• 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.
• Concurrent participation in another interventional study targeting cognition or wellbeing during the study period.

Sponsors & Collaborators

• Alzheimer Hellas: collaborator
• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

RECRUITING

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MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Despoina Moraitou, Professor, PhD

  Aristotle University of Thessaloniki, Department of Psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitra Vasileiou, M.Sc., PhD candidate

CONTACT

+30 6987304327; dvasilea@psy.auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Department of Psychology

Model Details: Parallel, two-arm randomized clinical trial. Participants with SCD or MCI are randomized within diagnosis to one of two arms: (1) multi-component Positive Psychology program delivered online (weekly small-group sessions for \~16 weeks plus brief home practice), or (2) treatment as usual (continuation of usual care with no additional structured program from the study team). Outcomes are assessed at baseline, mid-program, post-program, and follow-up.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 17, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

GR (1)