Virtual Reality-based Mindfulness Training for Mental Health After Stroke (VITAL)

Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients.

Aim: to evaluate the effect of a virtual reality (VR)-based medical device (HypnoVR®) on anxiety and stress reduction in patients with chronic stroke. Other outcomes, including depression, neurological fatigue and quality of life will be assessed.

Methodology: a randomized controlled trial including patients who had an ischemic or hemorrhagic stroke (>6 months) and experience significant anxiety - Hospital Anxiety and Depression Scale (HADS) ≥ 8 for anxiety. Intervention includes 3 weekly HypnoVR® sessions for 3 weeks (total: 9), with clinical assessments at baseline, post-intervention (end of week 3) and at a 8-week follow-up. The sessions will be supervised by a research assistant and will take place in our outpatient clinic. Participants will be randomly assigned to either an immediate treatment group or a delayed treatment group (waiting list), the latter acting as both controls and active participants.

Potential significance: VR-based therapeutic interventions are emerging as promising solutions to improve mental health but require solid scientific studies to assess their efficacy. This study provides a safe, non-invasive intervention for all included participants and could unveil its potential as an adjunctive therapy for mental health issues after stroke.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke (Subacute)
• Intervention / Treatment: Device: Virtual-reality hypnotherapy device

Detailed Description

Research aim: to assess the effectiveness of VR-based mindfulness training in outpatient stroke participants with mild-to-severe anxiety (HAD-anxiety ≥8). Secondary outcomes include depression, neurological fatigue, quality of life and sleep quality.

Methodology: randomized controlled trial of VR-based therapeutic intervention for patients with chronic (≥6 months) stroke and mild-to-severe anxiety (HAD-anxiety ≥8). The active group will benefit from 3 weekly HypnoVR® sessions for 3 weeks. This device is a head-mounted display providing medical hypnosis sessions with personalized visual (landscapes) and musical environments. Participants will be taken care of by a research assistant in our outpatient clinic and will experience 10- to 20-minute sessions. Clinical assessments include HADS for anxiety and depression, Multidimensional Fatigue Inventory Scale (MFIS), quality of life (SF-36) and sleep quality (Pittsburgh Sleep Quality Index). They will be measured at baseline (T0), post-intervention (T1, end of week 3) and at a 8-week follow-up (T2). A control group includes participants initially on a waiting list for 8 weeks (with T0-T1-T2 assessment) who will then benefit from the same active intervention (3 weekly HypnoVR® sessions for 3 weeks) with subsequent clinical reassessment (before starting the intervention (week 9, T0'), post-intervention (T1', end of week 11) and at a 16-week follow-up (T2').

Inclusion Criteria:

• Patient who had an ischemic or hemorrhagic stroke at least 6 months before inclusion
• aged ≥18 years
• HAD-anxiety scale score ≥8
• able to come to the clinic for study
• able to participate to sessions

Exclusion Criteria:

• blindness
• deafness
• severe vertigo
• language impairment (aphasia) or significant cognitive impairment limiting the understanding of the study scope
• psychiatric conditions such as schizophrenia or unstable paranoia
• Photo-sensitive epilepsy
• Cutaneous lesions on contact zone of the HypnoVR® headset

The therapeutic device is HypnoVR® Pico G3, a VR head-mounted visual and audio headset, which can be easily applied to the participant (https://hypnovr.io/fr/produits/hypnovr/). It has a CE mark, ISO certification (13485) and has been used for various indications, including peri-procedural pain management and anxiety reduction for adults and pediatric patients. To this day, more than 20 scientific publications on the use of HypnoVR® were released (https://hypnovr.io/en/research/).

Sessions: participants will comfortably lie supine during the session. They can select a landscape (beach, mountain, forest, underwater…), musical environment, voice (male or female) and language (10 languages available, among them French, English, German, Italian…). Each session will last between 10 and 20 minutes. The research assistant will help the participants to choose the environment thanks to a tactile tablet.

Clinical assessments and screening Screening for inclusion will be performed by clinicians of the Day Hospital at the Division of Neurorehabilitation, Department of Clinical Neurosciences, Geneva University Hospitals, Switzerland. Recruitment will therefore be performed by contacting out-patients of our daily practice or referred from other physicians.

Study physicians will perform an extensive assessment of the inclusion/exclusion criteria, give explanations about the study design and procedures, provide the expected potential benefits and propose signing of the consent form in case the patient fulfills study inclusion criteria and agrees to participate.

Clinical outcomes: between-group differences for active intervention group and control group (waiting list group) Primary outcome: Anxiety-HAD mean score at T1

Secondary outcomes:

• Percentage of patients below 8-point cutoff for HAD-anxiety score at T1
• Anxiety-HAD mean score at T2
• Post-intervention (T1) and Follow-up (T2) HAD-Depression score, fatigue (MFIS), quality of life (SF-36), and quality sleep (Pittburgh Sleep Quality Index) Potential adverse effects: vertigo, mild headache, transient fatigue

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Nicastro, MD; Phone Number: +41223723521; Email: nicolas.nicastro@hug.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • Geneva University Hospitals
    • Contact: Nicolas Nicastro, MD; Phone Number: +41223723521; Email: nicolas.nicastro@hug.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ischemic or hemorrhagic stroke >6 months before inclusion
• Anxiety-HAD score at inclusion >= 8

Exclusion Criteria:

• Blindness
• Deafness
• Photo-sensitive epilepsy
• unstable psychiatric condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Group (immediate); Virtual-reality based hypnotherapy session	Device: Virtual-reality hypnotherapy device; 10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device; Other Names: Hypno-VR
Other: Active Group (wait list); Wait list and acts as Control, then active intervention	Device: Virtual-reality hypnotherapy device; 10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device; Other Names: Hypno-VR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAD-Anxiety	Reduction of Hospital Anxiety and Depression (HAD) Anxiety Subscale	From enrollment to the end of the intervention (end of week 3)

Collaborators and Investigators

• Sponsor: Nicolas Nicastro

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stroke; anxiety; virtual reality
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Stroke; Anxiety Disorders
• Other Study ID Numbers: VITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No