Clinical Trial

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Recruiting
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Summary
The study investigates whether a virtual reality-based mindfulness based intervention can reduce impulsive aggression in individuals with schizophrenia or schizoaffective disorder. The primary goal is to evaluate whether mindfulness delivered via VR (MBI-VR) improves emotion regulation and engages the dorsomedial prefrontal cortex (dmPFC), a brain region involved in cognitive control and regulation of emotional responses. The study also examines whether these effects show a dose-related relationship. Participants will be randomized to receive different doses of MBI-VR intervention or distraction tasks and will complete repeated mindfulness VR sessions. Brain activity will be measured using functional magnetic resonance imaging (fMRI) during an emotion regulation task, along with clinical assessments of impulsive aggression related symptoms.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-20.
Trial Details
NCT Number NCT07434479
Lead Sponsor Manhattan Psychiatric Center
Collaborators: National Institute of Mental Health (NIMH)
Conditions Schizophrenia Disorder, Schizoaffecitve Disorder, Aggression
Enrollment 58 participants
Start Date 2026-06-05
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-10