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A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Interviews, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Neural target engagement is assessed via functional magnetic resonance imaging (fMRI), with a focus on activation of the dorsomedial prefrontal cortex (dmPFC) during an emotion regulation task."
  • "Screening and Baseline Procedures Potential participants are identified through a structured pre-screening process involving review of electronic and paper medical records to assess demographic eligibility, psychiatric diagnosis, aggression history, medication adherence, and medical suitability for MRI procedures."
  • "Inclusion and exclusion criteria are confirmed through clinical interview, collateral information, and medical record review."
  • "Functional Magnetic Resonance Imaging (fMRI) All participants undergo fMRI scanning at three time points: baseline, after 16 sessions, and after 24 sessions."
  • "The Simulator Sickness Questionnaire (SSQ) is administered following VR exposure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether mindfulness practice using virtual reality (VR) can reduce sudden aggression in adults ages 18–64 with schizophrenia or schizoaffective disorder. It compares different amounts of VR mindfulness with distraction tasks and checks effects on emotion control and brain activity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–64 years old.
  • Have schizophrenia or schizoaffective disorder, confirmed at screening.
  • Can give written consent, attend study visits, and complete study tasks.
  • Can read, speak, and understand English.
  • Take an atypical antipsychotic medicine, with treatment adjusted to your needs and no changes in the past 2 weeks.
  • Have medical records and a prescriber showing you took medicine as directed for the past 2 weeks.
  • Have a history of sudden aggression, with a score of 4 or higher on at least one item of the study's aggression scale.
  • Can see and hear well enough to complete tests and use VR.

Who can't join

  • Have had a head injury or have a disorder of the brain or nerves.
  • Are pregnant or breastfeeding, or have an unstable illness that makes the study unsafe.
  • Have thoughts of suicide with some intent to act at screening, with or without a specific plan. Self-harm without intent to die does not rule you out.
  • Have received electroconvulsive therapy (ECT), a treatment using electrical currents, within 6 months of the study.
  • Have metal in your body, fear of enclosed spaces, or do not meet the MRI safety rules.
  • Score below 4 on every item of the study's sudden-aggression scale.
  • Had a violent episode in the week before screening that required being kept alone, restraints, or as-needed medicine.
  • Have records showing you did not take medicine as directed in the past 2 weeks, including 2 or more missed doses or blood levels showing too little medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: TRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will: 1. 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. 2. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form. 3. Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment. 4. 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. 5. 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). 6. Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR 7. 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. 8. Adult or late adolescent, between 18 and 64 years of age at the time of informed consent. Exclusion Criteria: Participants will be excluded if they: 1. Have past head trauma 2. Diagnosed with a neurological disorder 3. Are pregnant or breastfeeding women as evidenced by the participant's medical record. 4. Have unstable medical illness that compromises the safety of the patient 5. 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) 6. 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) 7. Score \< 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003) 8. Have a violent episode requiring seclusion, restraints, or a prn within the week before screening 9. 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.

Study sites (2)

NY