Virtual reality mindfulness for reducing aggression in schizophrenia

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

We will test whether a virtual reality mindfulness program can help people with schizophrenia or schizoaffective disorder reduce impulsive aggression.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Manhattan Psychiatric Center (other)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT07434479 on ClinicalTrials.gov

What this trial studies

This randomized, parallel-group trial compares two doses of a mindfulness-based virtual reality (MBI-VR) program (16 vs. 24 sessions) against a non-immersive distraction control, with participants receiving repeated VR sessions. The study enrolls adults with schizophrenia or schizoaffective disorder who have a history of impulsive aggression and are on stable atypical antipsychotic treatment. Neural target engagement is measured with fMRI focusing on dorsomedial prefrontal cortex (dmPFC) activation during an emotion regulation task, and clinical scales track changes in impulsive aggression. The design also examines whether clinical and neural effects scale with the number of MBI-VR sessions (dose-related relationship).

Who should consider this trial

Good fit: Adults with schizophrenia or schizoaffective disorder who are fluent in English, on stable atypical antipsychotic treatment with documented recent medication adherence, and who have a history of impulsive aggression are the ideal candidates.

Not a fit: People without a history of impulsive aggression, those not on stable antipsychotic regimens, individuals unable to undergo MRI, or those with severe cognitive impairment or language barriers are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could provide a nonpharmacologic tool to improve emotion regulation and reduce impulsive aggression, potentially lowering risk of harm and improving daily functioning.

How similar studies have performed: Mindfulness programs and VR-based therapies have shown promise for emotion regulation in other conditions, but applying VR-delivered mindfulness specifically to impulsive aggression in schizophrenia with dmPFC target engagement is relatively novel and not yet widely tested.

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.

Where this trial is running

New York, New York and 1 other locations

• Manhattan Psychiatric Center — New York, New York, United States (RECRUITING)
• NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division — White Plains, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Anzalee Khan, PhD — Nathan Kline Institute for Psychiatric Research
• Study coordinator: Anzalee Khan, PhD

Conditions: Schizophrenia Disorder, Schizoaffecitve Disorder, Aggression, mindfulness based intervention, schizophrenia, dmPFC, emotion regulation, impulsive aggression