Nature-based Virtual Reality for Depression in Alzheimer’s Disease: Protocol of a Pilot Randomized Controlled Trial

INTRODUCTION: Alzheimer's disease (AD) is the most common form of dementia. Depression is common in AD, with limited evidence for efficacy of pharmacotherapy. Limited in-home non-pharmacological treatments for depression in AD underscore a need for novel in-home treatments. Virtual reality (VR) is an immersive audiovisual technology, which has been used in different clinical contexts. Exposure to nature can improve mental health, including the behavioural and psychological symptoms of dementia (BPSD). To our knowledge, in-home VR use has not been assessed in AD with depression (AD-D). This study aims to assess the feasibility of an in-home nature VR (N-VR) exposure versus an active non-immersive control intervention for individuals with AD-D. METHODS: This is a pilot, parallel group, assessor-blinded, randomized controlled trial, assessing a N-VR for AD-D. Participants (n=50) with AD-D are randomized (1:1) to N-VR vs. an active control intervention of nature-based videos. All participants receive the intervention as 15-min sessions delivered twice a week, for 4 weeks. Assessments are conducted remotely by assessors (via WebEx) blinded to randomized assignment at baseline, after each session, and within 7 days of completing the 4-week course to assess tolerability, feasibility, and acceptability. Participants also have the option to participate in a focus group at the end of the study. DATA ANALYSIS: Measures of feasibility, tolerability and acceptability, and preliminary clinical outcomes will be compared between the VR and control groups in intention-to-treat analyses. Qualitative data from the focus group is thematically analyzed. Relevant participant characteristics (e.g., age, sex, baseline clinical characteristics) will be described across groups and may be considered in exploratory or sensitivity analyses, recognizing the limited statistical power of this pilot study. DISCUSSION: If successful, this study has the potential to establish feasibility of remote VR for individuals with AD-D. CLINICAL TRIALS: NCT06732128 For the reporting of the RCT, the Consolidated Standards of Reporting Trials (CONSORT) has been used.