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NCT Number: NCT07473765

Virtual Reality for Anxiety Management in Persons With Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease characterized by death of motor neurons, resulting in weakness. Aside from motor-related progressive impairment, persons with ALS (pwALS) experience a burden of non-motor symptoms which have major influences on quality of life (QOL). This includes anxiety, found to be only second to function as greatest influence on QOL.

Exploring alternative technologies to improve access to anxiety management strategies for persons with ALS (pwALS) is a worthy endeavor. Virtual Reality (VR) is a technology increasingly used for mental health treatment and within clinical research. Anxiety treatment interventions utilizing VR can include exposure therapy or applied relaxation techniques, two of the more promising treatments for generalized anxiety disorder. The visual presentation of a virtual calm scenario can facilitate a persons' practice and mastery of relaxation, making the experience more vivid and real than the one that most individuals can create using their own imagination and memory.

This study will identify if a simple and accessible home VR guided relaxation exercise program can improve subjective anxiety symptoms in persons living with ALS, subsequently improving quality of life.

At 5 sites across Canada (Fredericton NB, Halifax NS, Kingston ON, Hamilton ON, and Saskatoon SK), persons with Amyotrophic Lateral Sclerosis will be identified by their treating physician and invited to participate during a typical interdisciplinary ALS clinic visit at their respective healthcare centre. Participants will be randomized to receive a virtual reality system for home-based relaxation therapy or to a control group which will receive no intervention. Outcome measurement will be completed at baseline prior to introduction of virtual reality and after every 4 weeks of intervention up to 12 weeks.

This multi-site randomized controlled trial aims to identify if a simple and accessible at-home virtual reality guided relaxation exercise program can improve subjective anxiety symptoms in persons with ALS and subsequently improve quality of life. It is our hope that this project will not only raise mental health awareness in persons with ALS but also provide an accessible and affordable opportunity to manage these overlooked aspects of ALS. This work could potentially be applied to other diagnoses which influence mental health and quality of life if deemed effective

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

  • Cognitive impairment that impacts ability to participate fully in assessments

Treatment and study plan

Virtual Reality Guided Breathing Exercise

Behavioral

Home-based guided breathing exercise using a virtual reality system application.

Primary outcomes

  1. State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

    Time frame: At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.

    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

Secondary outcomes

  1. ALS Functional Rating Scale - Revised (ALSFRS-R)

    Time frame: Baseline and 12 weeks.

    The ALS Functional Rating Scale (ALSFRS) is a validated rating instrument for monitoring the progression of disability in persons with ALS. The Revised ALSFRS (ALSFRS-R) retains the properties of the original scale and shows strong internal consistency and construct validity. The scale consists of 12 items, each with 5 possible responses rating impairment level, and covers various aspects of daily living

  2. ALS-Specific Quality of Life Short Form (ALSSQOL-SF)

    Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks.

    The Amyotrophic Lateral Sclerosis-Specific Quality of Life Short Form (ALSSQOL-SF) is a 20-item disease-specific global QOL instrument that has a short administration time suitable for clinical use, and can provide clinically useful, valid information about persons with ALS. Items are scored using a 0-10 rating scale.

  3. Patient Global Impression of Improvement Scale (PGI-I)

    Time frame: Completed at 12 week assessment only.

    Patient global impression of improvement (PGI-I) is a single-item global rating of change scale that asks an individual to rate the severity of a specific condition at baseline or to rate at endpoints the perceived change in his/her condition in response to therapy. There are seven possible responses (scored 1-7): very much better, much better, a little better, no change, a little worse, much worse, and very much worse

Study contacts

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

Maia Reynolds, Bachelor of Engineering

CONTACT

[email protected]

506-447-4379

Shane A McCullum, MScPT

CONTACT

[email protected]

506-447-4379

Sponsors and collaborators

Lead sponsor

Horizon Health Network

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • Nova Scotia Health Authority
  • Queen's University, Kingston, Ontario
  • University of Saskatchewan

Registry information

Official study title

Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis

Acronym: VR ALS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

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.

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