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The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial
Maria Stefania De Simone, Silvia Zabberoni, Alberto Luiz Cunha da Costa, Erika Tenaglia, Gaetano Tieri. Frontiers in Psychology, 2025-07-11
Topic: Risk, prevention and care in population studies
Background Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with an increased dementia and cognitive decline risk. Our aim is to test the effects of an immersive virtual reality (IVR) and telemedicine-based multi-component intervention, that combines cognitive training and health and lifestyle education program, in individuals with SCD. Methods To assess the efficacy of the intervention, a randomized, double-blinded controlled trial will be conducted on a sample of 75 individuals with SCD. Participants will be randomly assigned to one of three conditions: (a) multi-component intervention, including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention, including SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention for both cognitive training and education program. All interventions are implemented in IVR environment and will be administered through telemedicine approach. Interventions will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 min) over a period of 5 consecutive weeks. Outcome measures will be collected before and immediately after intervention. The primary outcome is the effect of the multi-component intervention in enhancing objective cognitive functioning. Secondary outcomes include changes in subjective cognitive functioning, psychiatric symptoms, quality of life and functional neural connectivity. Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy. Discussion Our results will provide new evidence of the efficacy of an innovative multi-component intervention integrating IVR and telemedicine in SCD individuals. Considering the relatively low costs and easy accessibility, it could be a valuable contribution to primary prevention initiatives for dementia risk reduction. Trial registration This trial was prospectively registered at ClinicalTrials.gov on May 24, 2024 (registration number: NCT06429215).
Key findings
- Background Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with an increased dementia and cognitive decline risk.
- Discussion Our results will provide new evidence of the efficacy of an innovative multi-component intervention integrating IVR and telemedicine in SCD individuals.
Why it matters
This is a study protocol for a randomized controlled trial that will test an immersive virtual reality and telemedicine-based intervention in 75 people with subjective cognitive decline. No results are available yet, so it cannot yet say whether the intervention affects dementia risk.
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Study details
- Participants75
- Evidence strengthHigh
How this study scored 46/100
Published in a peer-reviewed journal. Scored zero for study design and effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Frontiers in Psychology) |
| Journal's citation record | 3 / 4 | Frontiers in Psychology: journal h-index 313 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 75 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 1 / 7 | Cited 2 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.7 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 2 / 6 | Cited 1.3× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 2 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Gaetano Tieri: h-index 25 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Sapienza University of Rome: institution h-index 1,145 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 4 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40718565) |
| Free to read | 2 / 2 | Free to read |
| Total | 46 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.3389/fpsyg.2025.1591239
- PubMed: 40718565
- Original source →
- Free full text: Frontiers in Psychology →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
De Simone, M. S., Zabberoni, S., da Costa, A. L. C., Tenaglia, E., & Tieri, G. (2025). The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial. Frontiers in Psychology. https://doi.org/10.3389/fpsyg.2025.1591239
Vancouver
De Simone MS, Zabberoni S, da Costa ALC, Tenaglia E, Tieri G. The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial. Frontiers in Psychology. 2025. doi:10.3389/fpsyg.2025.1591239. PMID: 40718565.
BibTeX
@article{desimone2025-40718565,
author = {De Simone, Maria Stefania and Zabberoni, Silvia and da Costa, Alberto Luiz Cunha and Tenaglia, Erika and Tieri, Gaetano},
title = {{The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial}},
journal = {Frontiers in Psychology},
year = {2025},
doi = {10.3389/fpsyg.2025.1591239},
pmid = {40718565},
url = {https://doi.org/10.3389/fpsyg.2025.1591239}
}
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