Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06732128

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

Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease: a Pilot Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Centre for Addiction and Mental Health · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERnature-based virtual reality applications and videosParticipants will receive nature-based applications available on the Oculus platform, as well as nature-based 360 videos with the same content as the control group however in a 360 format.
OTHERnature-based videosParticipants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet).

Timeline

Start date
2025-01-06
Primary completion
2025-06-11
Completion
2025-11-11
First posted
2024-12-13
Last updated
2024-12-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06732128. Inclusion in this directory is not an endorsement.