Virtual Reality for Anxiety Management in Persons With Amyotrophic Lateral Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Guided Breathing Exercise.
- Who it may be relevant to
- Registry conditions: ALS (Amyotrophic Lateral Sclerosis). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis
Overview
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.
Detailed description
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
Interventions
- Behavioral Virtual Reality Guided Breathing Exercise
Home-based guided breathing exercise using a virtual reality system application.
Primary outcome measures
- State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) [Time frame: At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.]
Secondary outcome measures (3)
- ALS Functional Rating Scale - Revised (ALSFRS-R) [Time frame: Baseline and 12 weeks.]
- ALS-Specific Quality of Life Short Form (ALSSQOL-SF) [Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks.]
- Patient Global Impression of Improvement Scale (PGI-I) [Time frame: Completed at 12 week assessment only.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07473765 · 102307 · Chesley Research Fund