Virtual Reality-based Mindfulness Training for Mental Health After Stroke

Starting soon · Not applicable

Conditions studied: Stroke (Subacute)

In brief

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.

Key facts

Study ID
NCT07614373
Run by
Nicolas Nicastro
People needed
48
Starts
2027-04-01
Expected to finish
2029-03-31
Last updated by the study team
2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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