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

NCT06732128 | Recruiting

• 1 other identifier: VRN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

virtual reality

Outcome Measures

Primary Outcomes (3)

• 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)

  4 weeks

• Feasibility of nature-based virtual reality

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

  4 weeks

• Acceptability of nature-based virtual reality

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

  4 weeks

Secondary Outcomes (1)

• Depression in AD-D

  4 weeks

Other Outcomes (12)

• Caregiver participant exploratory outcome

  4 weeks

• AD-D participant exploratory outcome - quality of life

  4 weeks

• AD-D participant exploratory outcome - perceived stress

  4 weeks

Study Arms (2)

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.

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).

Other: nature-based videos

Interventions

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.

Treatment Group

nature-based videos OTHER

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

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• St. Mary's Research Center, Canada: collaborator

Study Sites (1)

Centre for Addictions and Mental Health (CAMH)

Toronto, Ontario, L5V 2X3, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Depression

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• HARMEHR SEKHON, PhD

  CAMH and McGill/St. Mary's Research Centre

  PRINCIPAL INVESTIGATOR

• Eric Brown, MD

  CAMH and UofT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashnie Sukhu, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 13, 2024
• Study Start: January 6, 2025
• Primary Completion: June 11, 2025
• Study Completion: November 11, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)