RecruitingNot ApplicableNCT07434479

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia


Sponsor

Manhattan Psychiatric Center

Enrollment

58 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests a virtual reality (VR) mindfulness app called TRIPP as a treatment to reduce aggression and improve wellbeing in people with schizophrenia, compared to a VR distraction programme. **You may be eligible if...** - You have a diagnosis of schizophrenia or a related psychotic disorder - You are an English speaker - You are willing and able to provide written consent and attend study visits - You are 18 or older **You may NOT be eligible if...** - You are unable to use virtual reality equipment safely (e.g., due to severe physical limitations) - You are currently in an acute psychiatric crisis - You are unable to give consent - You do not speak or read English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMindfulness-Based Virtual Reality Intervention

MBI VR is managed through a mobile device management (MDM) solution that supports full access remotely, to ensure the real-time data collection. Research staff members will be available at each session to assist with operational aspects of the MBI VR program (e.g., setting up the VR system, pausing the system if the participant expresses discomfort or distress). MBI delivered via VR is generally considered to be well-tolerated (Dascal et a., 2017); therefore, we do not expect any significant adverse events to occur. However, any seasickness-type of sensation can last for a few hours and even up to a week depending on many factors. While some people rarely experience VR motion sickness, others may continuously suffer symptoms of motion sickness for weeks. The most important factor is the extent of time of uninterrupted exposure. In the present study the exposure is 10 minutes, which is not expected to cause significant VR motion sickness.


Locations(2)

Manhattan Psychiatric Center

New York, New York, United States

NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division

White Plains, New York, United States

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NCT07434479


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