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

January 6, 2026 updated by: Dimitra Vasileiou, Aristotle University Of Thessaloniki

Application of Positive Psychology Interventions in Individuals With Early-stage Cognitive Decline Related to Dementia: Their Impact on Cognitive and Brain Functioning

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Dementia affects tens of millions of people and no curative therapy exists. Non-pharmacological interventions that are safe, scalable, and acceptable are therefore essential to delay decline and preserve functioning. Positive Psychology Interventions (PPIs) have shown promising effects on wellbeing and, more recently, on cognitive performance and neural markers in older adults with early cognitive decline. Positive Neuropsychology proposes that cultivating positive traits and eudaimonic wellbeing may support brain plasticity and cognitive control through multiple pathways, including increased engagement, motivation, and adoption of protective lifestyles. Building on this framework, the present trial tests an online, multi-component PPI tailored for adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The program is designed to be feasible, scalable, and low-risk, and to generate clinically relevant outcomes on cognition and brain functioning.

Objectives and Hypotheses Primary objective: determine whether the PPI produces greater improvements than Treatment As Usual (TAU) in (a) cognitive performance and (b) neurophysiological indices of brain functioning at post-intervention and at 9-month follow-up. Secondary objectives: evaluate effects on wellbeing and related psychosocial constructs (character strengths, mindfulness), and assess feasibility, adherence, and safety of online delivery. We hypothesize larger gains with PPI at 16 weeks and sustained benefits at follow-up, with potentially stronger effects in SCD than MCI.

Study Design and Setting Randomized, parallel-group, superiority behavioral trial with two diagnostic groups (SCD, MCI) recruited via Alzheimer Hellas. Within each cohort, participants are randomized 1:1 to PPI or TAU, yielding four arms (SCD-PPI, SCD-TAU, MCI-PPI, MCI-TAU). Randomization is concealed and performed by site personnel who are not involved in outcome assessment. The trial is minimal risk, uses no FDA-regulated products, and is approved by the Bioethics Committee of Alzheimer Hellas (Approval No. 99/5-6-2024). Outcome assessors are trained and, where feasible, blinded to assignment.

Participants Community-dwelling older adults with a documented diagnosis of SCD or MCI from Alzheimer Hellas according to site procedures are eligibl. Key capabilities include informed consent, sufficient sensory ability for testing, and access/ability to join online groups. Major neurological/psychiatric conditions that would confound outcomes, severe sensory impairment preventing testing, and concurrent participation in similar psychological programs during the trial are excluded. After consent, participants receive unique study IDs; identifiers are stored separately, with controlled access, and destroyed after data lock.

Intervention: Multicomponent Positive Psychology Program Delivery: weekly small-group videoconference sessions (~60 minutes) for 16 weeks led by trained psychologists.

Assessment schedule and procedures

Assessments occur at four time points:

T0 baseline (pre-randomization); T1 mid-intervention (~6 weeks); T2 post-intervention (~16 weeks; primary endpoint); T3 follow-up (~9 months post-T2). Attendance and home-practice adherence are tracked. Adverse events (AEs) are monitored each visit and during sessions per institutional policy.

Outcomes and Data Acquisition

Primary outcomes (analyzed from T0 to T3):

Cognitive performance: a composite derived from the REMEDES4Alzheimer computerized battery capturing episodic memory, working memory, attention subdomains, and executive functions, with minimized demographic bias.

Brain functioning: EEG and functional near-infrared spectroscopy (fNIRS) markers obtained during standardized cognitive tasks using harmonized acquisition and artifact-handling protocols.

Secondary outcomes: validated indices of wellbeing (PERMA-Profiler; PANAS) measured at all time points to model trajectories. Exploratory psychosocial measures include character strengths (VIA-114GR) and mindfulness (MAAS). Feasibility metrics include recruitment and retention, session attendance, and self-reported practice.

Sample Size and Power Four arms (SCD-PPI, SCD-TAU, MCI-PPI, MCI-TAU). A priori power calculations indicate a minimum of 32 participants per arm; target enrollment N=128.

Data management and quality control Data are captured on secure, password-protected platforms under unique study IDs; personally identifying information is maintained in a separate, access-restricted file. Quality procedures include range and logic checks, double verification of key variables, and standardized preprocessing pipelines for EEG/fNIRS feature extraction. After database lock, the re-identification log is destroyed. De-identified data may be shared as described in the IPD plan.

Statistical analysis Analyses follow the intent-to-treat principle with participants analyzed as randomized. For longitudinal outcomes, linear mixed-effects models estimate change and Arm×Time interactions, with random intercepts for participants and adjustment for diagnosis cohort (SCD/MCI) and prespecified covariates (e.g., age, sex, baseline value). The two primary outcomes will be tested with appropriate multiplicity control. EEG/fNIRS features are derived via prespecified pipelines and analyzed analogously. Exploratory mediation models will assess whether changes in mindfulness or strengths use relate to cognitive and neural changes.

Safety and ethics Risks are minimal (time burden; potential fatigue during EEG and fNIRS). Standardized procedures and scheduled breaks mitigate burden. AEs are recorded, assessed for relatedness and severity, and reported to the ethics committee per policy. The study complies with the Declaration of Helsinki and applicable data-protection laws.

Implementation and expected impact Remote delivery enhances access for older adults with mobility or caregiving constraints and lowers cost for participants and providers. If efficacious, the program can be scaled across community and clinical settings through brief facilitator training and manualized materials. The trial will provide mechanistic evidence on whether cultivating character strengths and mindfulness improves cognitive functioning and alters neural activity in early decline. Demonstration of sustained benefits at nine months would support PPIs as practical, low-risk adjuncts to usual care for SCD and MCI, with potential to delay progression.

Follow-up and data sharing All participants are invited to T3 follow-up to assess durability. De-identified datasets may be shared on reasonable request after publication, subject to approvals and data-use agreements, consistent with the IPD sharing plan.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dimitra Vasileiou, M.Sc., PhD candidate
  • Phone Number: +30 6987304327
  • Email: dvasilea@psy.auth.gr

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • Recruiting
        • Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive Psychology Intervention
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
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.
Active Comparator: Treatment as Usual
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognitive composite (z-score) from REMEDES4Alzheimer
Time Frame: 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

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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Character Strengths total score (VIA-114GR)
Time Frame: 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
VIA-114GR total (or mean) score; subscales analyzed exploratorily. Unit of measure: total/mean score (higher = greater strengths use)
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
Time Frame: 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
Total PERMA score; domain scores (P, E, R, M, A) examined secondarily. Unit of measure: score 0-10 (higher = better wellbeing)
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)
Time Frame: 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
Mean of the Mindful Attention Awareness Scale. Unit of measure: mean score 1-6 (higher = greater mindfulness)
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)
Time Frame: T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2)
PANAS Positive Affect subscale. Negative Affect analyzed exploratorily. Unit of measure: score 10-50 (higher = more positive affect)
T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Alzheimer Hellas

Investigators

  • Principal Investigator: Despoina Moraitou, Professor, PhD, Aristotle University of Thessaloniki, Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Estimated)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99/5-6-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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