Clinical trial NCT06732128: Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease
Official title: Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Depression
Keywords: virtual reality
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: St. Mary's Research Center, Canada
First posted: 2024-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tolerability of nature-based virtual reality
timeFrame: 4 weeks
measure: Feasibility of nature-based virtual reality
timeFrame: 4 weeks
measure: Acceptability of nature-based virtual reality
timeFrame: 4 weeks
Secondary outcomes:
measure: Depression in AD-D
timeFrame: 4 weeks
Other outcomes:
measure: Caregiver participant exploratory outcome
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - quality of life
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - perceived stress
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - attention
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - pleasure
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - sleep
timeFrame: 4 weeks
measure: AD-D exploratory outcome - calmness
timeFrame: 4 weeks
measure: AD-D exploratory outcome - loneliness
timeFrame: 4 weeks
measure: AD-D exploratory outcome - nature relatedness
timeFrame: 4 weeks
measure: AD-D participants exploratory outcome - activity
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - presence
timeFrame: 4 weeks
measure: AD-D participant exploratory outcome - immersion
timeFrame: 4 weeks
Locations:
city: Toronto
country: Canada
facility: Centre for Addictions and Mental Health (CAMH)
state: Ontario
Study officials:
affiliation: CAMH and McGill/St. Mary's Research Centre
name: HARMEHR SEKHON, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMH and UofT
name: Eric Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: