Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06732128

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addictions and Mental Health (CAMH)

Toronto, Ontario, L5V 2X3, Canada

Location status: Recruiting

Location contact

Ashnie Sukhu

CONTACT

[email protected]

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nature-based virtual reality applications and videos

Other

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

Other

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

Primary outcomes

  1. 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)

  2. Feasibility of nature-based virtual reality

    Time frame: 4 weeks

    The number of sessions completed and major/minor technical issues during the session.

  3. Acceptability of nature-based virtual reality

    Time frame: 4 weeks

    The Personal Involvement Inventory (PII) score mean after the last N-VR completed session.

Secondary outcomes

  1. Depression in AD-D

    Time frame: 4 weeks

    The Cornell Scale for Depression in Dementia (CSDD) score improvement over 4 weeks for the N-VR versus control group.

Other outcomes

  1. Caregiver participant exploratory outcome

    Time frame: 4 weeks

    The experiences of AD-D participants' caregivers with the VR intervention, VR usability with AD-D, what they liked/had challenges with, and feedback for future VR use with this population (qualitative-focus group).

  2. AD-D participant exploratory outcome - quality of life

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving quality of life in individuals with AD-D using the Quality of Life in Alzheimer's Disease (QOL-AD).

  3. AD-D participant exploratory outcome - perceived stress

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving stress in individuals with AD-D using the Perceived Stress Scale (PSS) and data from the Fitbit Charge 6.

  4. AD-D participant exploratory outcome - attention

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving attention in individuals with AD-D using the Montreal Cognitive Assessment (MoCA) attention task.

  5. AD-D participant exploratory outcome - pleasure

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving pleasure in individuals with AD-D using the Snaith-Hamilton Pleasure Scale (SHAPS).

  6. AD-D participant exploratory outcome - sleep

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving sleep in individuals with AD-D determined by the number of hours the participant slept, collected by the Fitbit Charge 6.

  7. AD-D exploratory outcome - calmness

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving calmness in individuals with AD-D using data from the Muse headband.

  8. AD-D exploratory outcome - loneliness

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in decreasing loneliness in individuals with AD-D using the UCLA loneliness scale.

  9. AD-D exploratory outcome - nature relatedness

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving nature relatedness in individuals with AD-D using the Nature-Relatedness Scale short version (NR-6).

  10. AD-D participants exploratory outcome - activity

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in increasing activity in individuals with AD-D, determined by baseline vs post-assessment average over 5 days using Fitbit.

  11. AD-D participant exploratory outcome - presence

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving presence in individuals with AD-D using the Slater-Usoh-Steed Presence Questionnaire (SUS).

  12. AD-D participant exploratory outcome - immersion

    Time frame: 4 weeks

    The preliminary efficacy of N-VR in improving immersion using the Immersive Tendencies Questionnaire (ITQ).

Study contacts

Contact information is provided by the study sponsor or research team.

Ashnie Sukhu, BSc

CONTACT

[email protected]

(416) 535-8501 ext. 31923

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • St. Mary's Research Center, Canada

Registry information

Official study title

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

Acronym: VRN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.