Effect of virtual reality aggression prevention training for forensic psychiatric patients (VRAPT): study protocol of a multi-center RCT.
Stéphanie Klein Tuente, Stefan Bogaerts, Sarah van IJzendoorn...
https://pubmed.ncbi.nlm.nih.gov/30081863Actively Recruiting
Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID07434479
A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
Led by Manhattan Psychiatric Center · Updated on 2026-02-25
58
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Manhattan Psychiatric Center
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a mindfulness-based intervention delivered through virtual reality (MBI-VR) can reduce impulsive aggression in people diagnosed with schizophrenia or schizoaffective disorder. The study aims to see if MBI-VR improves emotion regulation and activates the dorsomedial prefrontal cortex (dmPFC), a brain area important for controlling emotions. The trial also explores if the effects vary with different doses of the intervention. Participants will be randomly assigned to one of three groups: two groups receiving different doses of MBI-VR (16 sessions or 24 sessions) or a control group performing distraction tasks without immersive VR. MBI-VR sessions involve guided mindfulness exercises in visually dynamic and interactive virtual environments using a head-mounted display. Each session lasts about 10 minutes and includes mood and anxiety assessments before and after. The distraction group receives non-immersive activities like listening to music or viewing images, alongside usual inpatient care. Throughout the study, participants undergo clinical assessments, brain scans using functional magnetic resonance imaging (fMRI) during emotion regulation tasks, and regular monitoring of impulsive aggression symptoms. Scans and assessments occur at baseline, after 16 sessions, and after 24 sessions. Safety and tolerability, including possible VR motion sickness, are closely monitored. The total participation period covers the intervention and follow-up assessments, with ongoing usual psychiatric care provided.
CONDITIONS
Brief Title
A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
Who Can Participate
Age: 18Years - 64Years
All Genders
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with study requirements
- Fluent in written and spoken English
- On stable atypical antipsychotic treatment with no changes in 2 weeks before enrollment
- Documented good medication adherence in the 2 weeks before enrollment
- History of impulsive aggression with a score of 4 or higher on the Impulsive Aggression Factor of the IPAS
- Adequate visual and auditory abilities to complete assessments and see/hear VR stimuli
- Primary diagnosis of schizophrenia or schizoaffective disorder confirmed by SCID-5-RV
- Age between 18 and 64 years at informed consent
You will not qualify if you...
- History of past head trauma
- Diagnosis of a neurological disorder
- Pregnant or breastfeeding women
- Unstable medical illness compromising safety
- Significant suicidal ideation at screening (active suicidal ideation with intent)
- Electroconvulsive therapy within 6 months or contraindications for MRI
- Score less than 4 on all Impulsive Aggression Factor items on the IPAS
- Violent episode requiring seclusion, restraints, or PRN medication within one week before screening
- Suboptimal medication adherence in the 2 weeks prior to enrollment including missed doses or low plasma medication levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessments
Duration - 1 day
Participants complete baseline clinical, behavioral, and neuroimaging assessments including mood, aggression, medication adherence, and an fMRI scan.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants engage in up to 24 sessions of their assigned intervention over 6 weeks: Mindfulness-Based Virtual Reality sessions or Distraction Techniques control activities.
Up to 24 sessions, approximately 10 minutes each, with weekly clinical assessments
Neuroimaging and Clinical Assessments During Treatment
Duration - During 6-week treatment period
Participants complete fMRI scans and clinical assessments after 16 sessions and again after 24 sessions to evaluate neural target engagement and clinical outcomes.
2 fMRI visits and multiple clinical assessment visits timed with treatment sessions
Trial Site Locations
Total: 2 locations
1
Manhattan Psychiatric Center
New York, New York, United States, 10035
Actively Recruiting
2
NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division
White Plains, New York, United States, 10605
Actively Recruiting
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Research Team
A
Anzalee Khan, PhD
B
Benedicto Parker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Matthew J Hoptman
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Matthew J Hoptman, Daniel Antonius, Cristina J Mauro...
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Michael Fritz, Riad Shenar, Lizbeth Cardenas-Morales...
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A M Dale
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Kirk Warren Brown, Richard M Ryan
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