RECRUITINGINTERVENTIONAL

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: TRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will: 1. Is willing and able to provide written willing to sign a consent form 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 willing to sign a consent form 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 willing to sign a consent form. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

Mindfulness-Based Virtual Reality Intervention

MBI VR is managed through a mobile device management (MDM) solution that supports full access remotely, to ensure the real-time data collection. Research staff members will be available at each session to assist with operational aspects of the MBI VR program (e.g., setting up the VR system, pausing the system if the participant expresses discomfort or distress). MBI delivered via VR is generally considered to be well-tolerated (Dascal et a., 2017); therefore, we do not expect any significant adverse events to occur. However, any seasickness-type of sensation can last for a few hours and even up to a week depending on many factors. While some people rarely experience VR motion sickness, others may continuously suffer symptoms of motion sickness for weeks. The most important factor is the extent of time of uninterrupted exposure. In the present study the exposure is 10 minutes, which is not expected to cause significant VR motion sickness.

Locations (2)

Manhattan Psychiatric Center

New York, New York, United States

NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division

White Plains, New York, United States