Virtual Reality-based Mindfulness Training for Mental Health After Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicolas Nicastro

About this trial

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.

Eligibility criteria

Qualifiers

Ischemic or hemorrhagic stroke >6 months before inclusion

Anxiety-HAD score at inclusion >= 8

Disqualifiers

Blindness

Deafness

Photo-sensitive epilepsy

unstable psychiatric condition

Trial design

Treatments tested in this trial

  • Virtual-reality hypnotherapy device

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nicolas Nicastro

Lead sponsor

University Hospital, Geneva

Sponsor institution