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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Virtual-reality hypnotherapy device

    Device

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Active Group (immediate)Experimental treatment 1 intervention
Group B: Active Group (wait list)Other 1 intervention

Trial outcomes

Primary outcomes

1

HAD-Anxiety

Reduction of Hospital Anxiety and Depression (HAD) Anxiety Subscale

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Nicolas Nicastro

Lead sponsor

University Hospital, Geneva

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: