A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Prior treatment

• 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.

Other illness

• Diagnosed with a neurological disorder
• Have unstable medical illness that compromises the safety of the patient

Other

• 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)

• 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.