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 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 46 |
| Population | People with amyotrophic lateral sclerosis (ALS) |
| Intervention | traditional mindfulness |
| Duration | 8-week intervention, 3-month follow-up |
| Topics | Meditation |
| Keywords | Cognitive impairment Mindfulness-based interventions mbi Psychological care Quality of life Virtual reality vr |
| Citations | 3 |
| Key findings | 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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 15
- Mindfulness-based interventions: an overall review British Medical Bulletin April 21, 2021
- Virtual Reality Mindfulness for Meta-Competence Training among People with Different Mental Disorders: A Systematic Review Psychiatry International October 18, 2023
- The effectiveness of immersive virtual reality (VR) based mindfulness training on improvement mental-health in adults: A narrative systematic review. Explore August 1, 2022
- Mediating Mindfulness-Based Interventions with Virtual Reality in Non-Clinical Populations: The State-of-the-Art. Healthcare June 29, 2022
- An online non-meditative mindfulness intervention for people with ALS and their caregivers: a randomized controlled trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration February 2022
and 10 more in the library