JMIR Publications

ABSTRACT

Background:

Older adults often face loneliness due to chronic illness or loss of close ones, a situation worsened by COVID-19. Increased loneliness heightens the risk of diseases, especially dementia, necessitating urgent action.

Objective:

This study aims to assess the impact of a virtual reality (VR)-based open-air bath program on depression and loneliness in elderly individuals with Subjective Cognitive Decline/Mild Cognitive Impairment (SCD/MCI) attending our Dementia Medical Centre and evaluate the feasibility (participant recruitment and adherence) and measuring program enjoyment and satisfaction.

Methods:

The study design is a crossover trial with a 1:1 ratio wherein 12 participants will be randomly assigned to Groups 1 and 2, with Group 2 serving as a waitlist control, and the VR program will be conducted six times (monthly). Group 1 will participate from the program's commencement and continue for 6 months, followed by an observation period from months 7 to 12. Group 2 will participate from months 7 to 12, with an observation period from months 1 to 6. Cognitive tests, psychiatric assessments, and the UCLA loneliness scale will be conducted before the study, at 6 months, and at 12 months. Results will be analyzed using repeated measures ANOVA. Head MRI and SPECT scans will be performed pre- and post-VR program to evaluate changes and effects on brain regions.

Results:

Recruitment began in September 2023, and data collection is expected to be completed by March 2025. Complete study results will be published by September 2025.

Conclusions:

The study examines the preliminary effects of VR on loneliness in predementia seniors through open-air bath simulations. Virtual reality experiences could benefit this population, particularly those with limited outdoor activities. Quantifying VR's impact will aid in determining the size for a larger clinical trial. Qualitative results will inform participation mechanisms and guide the implementation and design of future trials. Clinical Trial: The protocol and informed consent were approved by the Ethical Review Board of Kyoto Prefectural University of Medicine on October 31, 2023 (ERB-C-2978). The study has been registered in the University Hospital Medical Information Network (UMIN) on November 1, 2023 (Trial Registration Number: 000052667).