Actively Recruiting
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
95 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
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.
CONDITIONS
Official Title
A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
Who Can Participate
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 and able to understand the consent form
- On stable and optimized atypical antipsychotic treatment with no changes in past 2 weeks
- Demonstrated good medication adherence for at least 2 weeks prior to enrollment
- History of impulsive aggression with a score of 4 or higher on the Impulsive Aggression Factor of the Impulsive-Premeditated Aggression Scale
- Adequate vision and hearing 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 the time of consent
You will not qualify if you...
- History of head trauma
- Diagnosis of a neurological disorder
- Pregnant or breastfeeding women
- Unstable medical illness compromising safety
- Significant suicidal ideation with intent or plan at screening
- Electroconvulsive therapy within past 6 months, presence of metal in body, claustrophobia, or failure to pass MRI safety screening
- Score less than 4 on all items of the Impulsive Aggression Factor on the IPAS
- Recent violent episode requiring seclusion, restraints, or PRN medication within 1 week before screening
- Suboptimal medication adherence in the 2 weeks before enrollment, including missed doses or plasma levels indicating inadequate dosing
AI-Screening
AI-Powered Screening
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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
Research Team
A
Anzalee Khan, PhD
CONTACT
B
Benedicto Parker
CONTACT
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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