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

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