VR mindfulness may tame aggression in schizophrenia
NCT ID NCT07434479
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a virtual reality mindfulness app can help people with schizophrenia or schizoaffective disorder control impulsive aggression. About 58 participants will use the VR app or do distraction tasks, and have their brain activity measured with fMRI. The goal is to see if VR mindfulness improves emotion regulation and reduces aggressive behavior.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Manhattan Psychiatric Center
RECRUITINGNew York, New York, 10035, United States
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NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division
RECRUITINGWhite Plains, New York, 10605, United States
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Other studies related to the condition(s) this trial covers.
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