Virtual Reality-based Mindfulness Training for Mental Health After Stroke

NCT07614373 | Not Yet Recruiting

• 1 other identifier: VITAL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke (Subacute)

Keywords

stroke; virtual reality; anxiety

Outcome Measures

Primary Outcomes (1)

• HAD-Anxiety

  Reduction of Hospital Anxiety and Depression (HAD) Anxiety Subscale

  From enrollment to the end of the intervention (end of week 3)

Study Arms (2)

Active Group (immediate)

EXPERIMENTAL

Virtual-reality based hypnotherapy session

Device: Virtual-reality hypnotherapy device

Active Group (wait list)

OTHER

Wait list and acts as Control, then active intervention

Device: Virtual-reality hypnotherapy device

Interventions

Virtual-reality hypnotherapy device DEVICE

10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device

Also known as: Hypno-VR

Active Group (immediate); Active Group (wait list)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Nicolas Nicastro: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Stroke; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Central Study Contacts

Nicolas Nicastro, MD

CONTACT

+41223723521; nicolas.nicastro@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CH (1)