A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Conditions

• Aggression
• Schizoaffecitve Disorder
• Schizophrenia Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Mindfulness-Based Virtual Reality Intervention — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jun 5, 2026

Status verified

Jan 2026

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

58 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Mindfulness-Based Virtual Reality (MBI-VR)
  The MBI VR is developed by TRIPP. Instead of naturalistic scenic images, the TRIPP MBI VR features intricate visually dynamic environments such as colorful surreal landscapes, light-based effects, floating shapes and immersive spatial soundscapes. These visuals encourage participants to focus on flowing designs, fostering a sense of engagement. The game-like quality of the virtual environment includes interactive elements where participants can manipulate shapes or respond to stimuli. This interactivity can enhance engagement, turning mindfulness meditation into a game-like playful and exploratory experience. The TRIPP MBI VR program offers guided sessions led by a virtual instructor, who provides verbal cues and instructions for the practice. This guidance includes breathing techniques, body awareness exercises, or instructions for focusing attention.
• Other: Distraction Tasks
  Tasks will include standard rehabilitative inpatient treatment as usual (TAU) which includes wellness and recovery sessions, coping skills, understanding medications, discharge preparation, and behavioral sessions and Distraction Techniques. Distraction Techniques that encompass activities designed to engage participants and divert their attention from discomfort or distressing thoughts. These techniques can include: 1. Listening to Music: Participants may listen to calming or enjoyable music, which can help reduce anxiety and enhance relaxation by promoting positive emotional states. 2. Viewing Images: Participants may look at carefully selected images or visuals, such as nature scenes, art, or other soothing imagery. This can create a sense of calm and provide a mental escape from their current situation. 3. Watching Videos: Participants may engage with short videos or clips that are designed to be engaging, aiming to promote distraction and engage their interest.

Primary Outcome Measure

Short UPPS-P Impulsive Behavior Scale [ Time Frame: Will be conducted at Baseline (Day 1), Week 4 (after completion of 16 sessions of MBI-VR or Distraction Tasks), Week 6 (after completion of 24 sessions of MPV-VR or Distraction Tasks) ]

Central Contacts

• Anzalee Khan, PhD
  646-766-5876
  [email protected]
• Benedicto Parker
  212-961-8992
  [email protected]

Locations (2)

Find similar trials in New York, NY

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