Virtual Reality for Anxiety Management in Persons With Amyotrophic Lateral Sclerosis
VR ALS
Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
Virtual Reality (VR) is gaining traction as a new and innovative leisure to augment healthcare services. Several benefits of the leisure experience, such as distraction and full sensory immersion, have demonstrated a potential to significantly impact the field of healthcare through pain reduction, anxiety reduction, and is seen as an innovative approach to motor learning. Persons with ALS (pwALS) have a high prevalence of anxiety over the course of their illness, which has a negative impact on their quality of life, and the quality of life of those closest to them. The use of VR for anxiety management and subsequent quality of life improvement has yet to be explored in the ALS population. For individuals with ALS, VR can be both (1) an escape from the reality of living day to day with a progressive fatal diagnosis; and (2) the opportunity to potentially improve anxiety, both of which are linked to the quality of life of individuals living with ALS. Our hypothesis is that a simple and accessible home VR-guided relaxation exercise program can improve subjective anxiety symptoms in a person living with ALS and subsequently improve quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 16, 2026
March 1, 2026
12 months
March 11, 2026
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
The STICSA is a self-report questionnaire consisting of 42-items rated on a 4-point Likert scale from 1 (Almost never or Not at all) to 4 (Almost always or Very much so), where 21 items are rating how you feel in the present moment, and the same 21 items are rated based on how you feel in general
At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.
Secondary Outcomes (3)
ALS Functional Rating Scale - Revised (ALSFRS-R)
Baseline and 12 weeks.
ALS-Specific Quality of Life Short Form (ALSSQOL-SF)
Baseline, 4 weeks, 8 weeks and 12 weeks.
Patient Global Impression of Improvement Scale (PGI-I)
Completed at 12 week assessment only.
Study Arms (2)
Virtual Reality relaxation therapy
EXPERIMENTALHome-based relaxation therapy using a Virtual Reality system with a via guided breathing exercise application.
Control Group
NO INTERVENTIONPersons with ALS will be monitored with the same outcome measures as the intervention group, but no intervention will be provided.
Interventions
Home-based guided breathing exercise using a virtual reality system application.
Eligibility Criteria
You may qualify if:
- Diagnosed with ALS (gold coast or El-Escorial), or ALS variants of flail limb, progressive muscle atrophy, UMN or LMN predominant
- Able to use VR device with no negative effects (i.e. headaches, vision changes, dizziness, nausea, disorientation)
You may not qualify if:
- \- Cognitive impairment that impacts ability to participate fully in assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Saskatchewancollaborator
- Nova Scotia Health Authoritycollaborator
- Hamilton Health Sciences Corporationcollaborator
- Queen's University, Kingston, Ontariocollaborator
- Horizon Health Networklead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colleen O'Connell, MD FRCPC
Horizon Health Network
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Manager
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 16, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share