Positive Psychology for Early Cognitive Decline: Effects on Cognitive and Brain Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAristotle University Of Thessaloniki
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Positive Psychology Intervention
BehavioralOnline, 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.
Treatment as usual (TAU)
BehavioralStructured 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 groups
128 Participants
are divided into 2 treatment groupsGroup A: Positive Psychology InterventionExperimental treatment 1 intervention
Group B: Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
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 T22
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.
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)3
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
Time Frame: T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2)Secondary outcomes
1
Character Strengths total score (VIA-114GR)
VIA-114GR total (or mean) score; subscales analyzed exploratorily. Unit of measure: total/mean score (higher = greater strengths use)
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 T22
Wellbeing - PERMA-Profiler total score
Total PERMA score; domain scores (P, E, R, M, A) examined secondarily. Unit of measure: score 0-10 (higher = better wellbeing)
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 T23
Mindfulness (MAAS total)
Mean of the Mindful Attention Awareness Scale. Unit of measure: mean score 1-6 (higher = greater mindfulness)
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 T24
Positive Affect (PANAS)
PANAS Positive Affect subscale. Negative Affect analyzed exploratorily. Unit of measure: score 10-50 (higher = more positive affect)
Time frame
T0 (Baseline), T2 (~16 weeks; primary endpoint), T3 (~9 months after T2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aristotle University Of Thessaloniki
Lead sponsor
Alzheimer Hellas
Collaborator
Source ClinicalTrials.gov