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Effects of virtual reality mindfulness on cognition and well-being in ALS: A randomized trial protocol.

Juliette Faure-De Baets, Jeremy Besnard, Frédéric Banville, Julien Cassereau, Philippe Allain

Contemporary clinical trials May 1, 2025 DOI: 10.1016/j.cct.2025.107876 via PubMed

Summary

A randomized controlled trial will test whether virtual-reality-based mindfulness training improves quality of life more than traditional mindfulness for people with amyotrophic lateral sclerosis (ALS). Forty-six participants will be randomly assigned to an eight-week mindfulness program delivered either through VR or in a conventional format. The primary outcome is quality of life, measured by the ALS-Specific Quality of Life Scale; secondary outcomes include cognitive function, anxiety, depression, behavioral changes, and mindfulness propensity, assessed at baseline, after the intervention, and three months later. The study also examines VR usability and accessibility challenges. If effective, VR mindfulness could make psychological support more accessible for patients with severe physical limitations.

Study at a glance

Characteristics Randomized controlled trial Peer reviewed
Sample size 46
Population People with amyotrophic lateral sclerosis (ALS)
Keywords Cognitive impairment Mindfulness-based interventions mbi Psychological care Quality of life Virtual reality vr
Citations 3
Key finding The study will evaluate whether VR-based mindfulness improves quality of life more than traditional mindfulness for ALS patients.

Abstract

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease primarily affecting motor neurons but also leading to significant non-motor symptoms, including cognitive impairments, anxiety, depression, and behavioral changes, which severely impact quality of life. While mindfulness-based interventions (MBIs) have shown promise in alleviating psychological distress, their accessibility is often limited due to patients' physical impairments. Virtual reality (VR) could enhance engagement and immersion, offering a novel, more inclusive therapeutic approach. This randomized controlled trial (RCT) aims to evaluate the efficacy of a VR-based MBI compared to traditional mindfulness for ALS patients. Forty-six participants will be randomly assigned to an eight-week mindfulness program delivered either via VR or in a conventional format. The primary outcome is quality of life, assessed using the ALS-Specific Quality of Life Scale (ALSSQOL-R). Secondary outcomes include cognitive function, anxiety, depression, behavioral changes, and mindfulness propensity, evaluated at baseline, post-intervention, and three-month follow-up. The study will also examine VR usability and potential accessibility challenges for ALS patients. By addressing a critical gap in non-pharmacological psychological care, this study will provide key insights into the feasibility and benefits of VR-based MBIs. If effective, VR mindfulness could offer an innovative, scalable solution to improve emotional well-being and quality of life in ALS, making psychological support more accessible for patients with severe physical limitations.

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