Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Depression

• Registration Number: NCT06732128
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

Behavioural and psychological symptoms of dementia (BPSD), such as depression affect up to 90% patients with dementia. Non-pharmacological treatment of BPSD, can be difficult to access, require caregiver support, travel, and often have long waiting lists. Virtual reality (VR) is an innovative, portable, immersive, and accessible technology which can be used in-home. More information is required on the feasibility of using VR in-home with older adults with dementia.

Our study will offer a 4-week program of 15-minutes sessions, twice per week nature-based VR program for BPSD delivered in-home by virtual reality (VR). Additionally, caregivers will have the option of taking part in the study and provide feedback regarding the VR intervention. If successful, this project has the potential to prolong aging in place for individuals with BPSD, as BPSD is a significant factor in institutionalization.

Detailed Description

The burden of dementia is rapidly growing, affecting nearly 50 million individuals globally and costing $818 billion dollars yearly. Alzheimer's disease (AD) is the most common form of dementia. AD includes changes in mood and behavior, referred to as the behavioral and psychological symptoms of dementia (BPSD). Depression is among the most common BPSD, impacting 50% of older adults with AD. Existing pharmacological treatment for depressive symptoms in AD (AD-D) lack evidence for efficacy and have many potential side effects (e.g. cognitive impairments, falls, mortality), Non-pharmacological interventions have been recommended but are associated with significant challenges such as travel, cost and the difficulty in accessing specialized therapists.

Virtual reality (VR), an immersive audiovisual technology, can address these challenges as it is an accessible and cost-effective intervention which can be delivered in a variety of settings. VR can easily be delivered in-home, and therefore address many of the limitations of traditionally delivered non-pharmacological interventions, such as accessibility, intervention non-adherence and difficulties with maintaining intervention frequency. Additional technology will be utilized to collect physiological data such as movement using the Fitbit Charge 6 and a Muse headband will measure electroencephalogram (EEG). Previous literature on VR based intervention for older adults is limited, with very few randomized control trials, rather it is primarily case studies, cross-sectional studies, and non-immersive VR. However, there are no studies assessing in-home VR for individuals with AD or for AD-D.

We propose a pilot randomized controlled trial (RCT) to assess nature-based VR intervention (N-VR) for AD-D. We will randomize (1:1) 50 participants with AD-D to N-VR vs. an active control intervention of various nature-based videos (N-CI). All participants will receive the intervention as 15-min sessions delivered twice a week, assessor-blinded, for 4 weeks. Assessments will be conducted at baseline, within 7 days of starting the intervention, at follow-up, within 7 days of completing the 4-week course, and after each 15-min session.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Study Start: 2025-01-06
• Primary Completion: 2025-06-11
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosis of mild to early-moderate stage AD (including mixed dementia with AD) using the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Criteria
• Age of 50 years or older
• Medical stability to participate in the trial
• Patient Health Questionnaire score 5-14
• Investigator judgement on whether the participant is comfortable with technology
• Access to WiFi and a smart device for connecting on WebEx and downloading the Fitbit and Muse applications
• Have someone available to be present during all sessions

Exclusion Criteria

• Unstable medical or psychiatric condition, including substance use based on an investigator opinion
• Visual or hearing impairments that would impair participation
• Patient Health Questionnaire score 15-27 and/or score of 1 or 2 in section E question 1 of the Cornell Scale for Depression in Dementia
• Any other reason, which will make the study participation intolerable for the participant in the opinion of the study investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability of nature-based virtual reality	4 weeks	Hypothesis 1a (Tolerability): Using the Simulator Sickness Questionnaire (SSQ) at the end of the last session, the mean SSQ score for N-VR group will be less than 10 (with 10 or more being the cut-off for clinically significant cybersickness)
Feasibility of nature-based virtual reality	4 weeks	The number of sessions completed and major/minor technical issues during the session.
Acceptability of nature-based virtual reality	4 weeks	The Personal Involvement Inventory (PII) score mean after the last N-VR completed session.

Secondary Outcome Measures

Name	Time	Method
Depression in AD-D	4 weeks	The Cornell Scale for Depression in Dementia (CSDD) score improvement over 4 weeks for the N-VR versus control group.

Trial Locations

Locations (1)

Centre for Addictions and Mental Health (CAMH); 🇨🇦 Toronto, Ontario, Canada