Alzheimer DiseaseVRNNCT06732128
Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease
A study testing nature-based virtual reality applications and videos and nature-based videos in people with Alzheimer Disease and Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Depression
- What is being tested?
- nature-based virtual reality applications and videos and nature-based videos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2025to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addictions and Mental Health (CAMH)
Toronto, Ontario, L5V 2X3
Ashnie Sukhu, ashnie.sukhu@camh.ca
About this study
Official title: Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease: a Pilot Randomized Controlled Trial
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.
Read the 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
- Alzheimer Disease, Depression
- Being tested
- nature-based virtual reality applications and videos, nature-based videos
- Keywords
- virtual reality
- Medical subject headings
- Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nature-based virtual reality applications and videosOther
Participants 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.
nature-based videosOther
Participants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants 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. Receives: Other: nature-based virtual reality applications and videos |
| Control Group | Active comparator | Participants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet). Receives: Other: nature-based videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of nature-based virtual reality
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)
Measured: 4 weeks
Feasibility of nature-based virtual reality
The number of sessions completed and major/minor technical issues during the session.
Measured: 4 weeks
Acceptability of nature-based virtual reality
The Personal Involvement Inventory (PII) score mean after the last N-VR completed session.
Measured: 4 weeks
Secondary outcomes (1)
Depression in AD-D
The Cornell Scale for Depression in Dementia (CSDD) score improvement over 4 weeks for the N-VR versus control group.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start6 Jan 2025 (estimated)
- Primary completion11 Jun 2025 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- St. Mary's Research Center, Canada
- Responsible party
- Sponsor
- Investigators
- HARMEHR SEKHON, PhD, Principal investigator, CAMH and McGill/St. Mary's Research CentreEric Brown, MD, Principal investigator, CAMH and UofT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732128
- Sponsor's protocol ID
- VRN
- Acronym
- VRN
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06732128
- Acronym / sponsor ID
- VRN / VRN
- Conditions
- Alzheimer Disease, Depression
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- St. Mary's Research Center, Canada
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 11 Jun 2025 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: nature-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. |
| Control Group | Active comparator | Other: nature-based videosParticipants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nature-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. | Other | Treatment Group |
| nature-based videosParticipants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet). | Other | Control Group |
Primary outcome
Tolerability of nature-based virtual reality
Time frame: 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
Time frame: 4 weeks
The number of sessions completed and major/minor technical issues during the session.
Acceptability of nature-based virtual reality
Time frame: 4 weeks
The Personal Involvement Inventory (PII) score mean after the last N-VR completed session.
1 secondary outcome
Depression in AD-D
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease
Transcranial Alternating Current Stimulation, Alzheimer Disease (AD)
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HARMEHR SEKHON, PhD principal investigator
CAMH and McGill/St. Mary's Research Centre
Eric Brown, MD principal investigator
CAMH and UofT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nature-based virtual reality applications and videos and nature-based videos in people with Alzheimer Disease and Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashnie Sukhu, BSc ((416) 535-8501 ext. 31923, ashnie.sukhu@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of nature-based virtual reality (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.