Virtual Reality Mindfulness for Aggression in Schizophrenia and Schizoaffective Disorder
Tests virtual reality mindfulness for impulsive aggression in people with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
Key facts
- Where
- New York and White Plains, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07434479, who can take part
Where in United States
- Manhattan Psychiatric CenterNew York, United StatesTaking people
- NewYork-Presbyterian/Weill Cornell Medical Center Westchester DivisionWhite Plains, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Manhattan Psychiatric Center
- Trial code
- NCT07434479
- Record updated
- 10 June 2026
- Original description
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.Read full original descriptionShow less
A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
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.
Inclusion: TRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will:; Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments; Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form; Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment; Demonstrate documented evidence of good medication adherence for the 2 weeks prior to enrollment, as determined by electronic medication records review and prescriber reported adherence to prescribed schedule as documented in the participant's medical records; Have a history of impulsive aggression as assessed by a score of ≥ 4 on any item on Impulsive Aggression Factor (IA) on the Impulsive- Premeditated Aggression Scale (IPAS; Stanford et al., 2003); Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR; Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia or schizoaffective disorder, as defined in the SCID-5-RV at the Screening Visit; Adult or late adolescent, between 18 and 64 years of age at the time of informed consent.
Exclusion: Are on Electroconvulsive therapy (ECT) within 6 months of the study, participants with metal in their bodies or who have claustrophobia or who do not pass the criteria in NKI's Magnetic Resonance Safety Questionnaire (MRSQ); Have a violent episode requiring seclusion, restraints, or a prn within the week before screening; Evidence of suboptimal medication adherence in the 2 weeks prior to enrollment, as determined by electronic medication records review, and demonstrated by prescriber reported non- adherence to prescribed schedule. Suboptimal adherence includes missed doses (two of more missed doses within the past 2 weeks) or plasma levels indicating that the participant is not receiving the intended therapeutic dose; Diagnosed with a neurological disorder; Have unstable medical illness that compromises the safety of the patient; Participants will be excluded if they:; Have past head trauma; Are pregnant or breastfeeding women as evidenced by the participant's medical record; Have significant suicidal ideation at screening (as assessed by the Columbia - Suicide Severity Rating Scale (C-SSRS; participant answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS; Non-suicidal self-injurious behavior is not exclusionary); Score < 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003).