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

NCT06732128 · Centre for Addiction and Mental Health
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Official title
Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease: a Pilot Randomized Controlled Trial
About this study
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.
Eligibility criteria
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
Enrollment target: 50 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-01-06
Estimated completion: 2025-11-11
Last updated: 2024-12-13
Interventions
Other: nature-based virtual reality applications and videosOther: nature-based videos
Primary outcomes
  • Tolerability of nature-based virtual reality (4 weeks)
  • Feasibility of nature-based virtual reality (4 weeks)
  • Acceptability of nature-based virtual reality (4 weeks)
Sponsor
Centre for Addiction and Mental Health · other
With: St. Mary's Research Center, Canada
Contacts & investigators
ContactAshnie Sukhu, BSc · contact · ashnie.sukhu@camh.ca · (416) 535-8501
InvestigatorHARMEHR SEKHON, PhD · principal_investigator, CAMH and McGill/St. Mary's Research Centre
InvestigatorEric Brown, MD · principal_investigator, CAMH and UofT
All locations (1)
Centre for Addictions and Mental Health (CAMH)Recruiting
Toronto, Ontario, Canada
Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease · TrialPath