Recruiting

VR for BPSD

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06732128

Conditions

Alzheimer Disease

Depression

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

nature-based virtual reality applications and videos

nature-based videos

Study Details

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.

Conditions

Alzheimer Disease

Depression

Study ID

NCT06732128

Start date

Jan 6, 2025

Status verified date

Nov, 2024

Completion date

Nov 11, 2025

Anticipated

Primary completion date

Jun 11, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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.

active comparator: Control Group

Participants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet).

Interventions

nature-based virtual reality applications and videos

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 videos

Participants will receive YouTube links to watch nature-based videos on a device (e.g., a tablet).

Primary outcome measure

  • Tolerability of nature-based virtual reality [ Time Frame: 4 weeks ]
  • Feasibility of nature-based virtual reality [ Time Frame: 4 weeks ]
  • Acceptability of nature-based virtual reality [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Ashnie Sukhu, BSc

(416) 535-8501ashnie.sukhu@camh.ca

Locations

Centre for Addictions and Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada, L5V 2X3

Contacts

Ashnie Sukhu

ashnie.sukhu@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Dec 13, 2024

Last verified

Nov, 2024

Keywords

  • virtual reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2024-12-13.