Application of Positive Psychology Interventions in Individuals With Early-stage Cognitive Decline Related to Dementia: Their Impact on Cognitive and Brain Functioning
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Global cognitive composite (z-score) from REMEDES4Alzheimer
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Positive Psychology Intervention (Behavioral)
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).
Intervention: Treatment as usual (TAU) (Behavioral)
Outcomes
Primary Outcomes
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)
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.
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)
Secondary Outcomes
- 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))
Investigators
Dimitra Vasileiou
PhD Candidate, Department of Psychology
Aristotle University Of Thessaloniki