NCT07434479 A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
| NCT ID | NCT07434479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Manhattan Psychiatric Center |
| Condition | Schizophrenia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-06-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2026-06-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Anzalee Khan, PhD
PRINCIPAL INVESTIGATOR
Nathan Kline Institute for Psychiatric Research
Frequently Asked Questions
Who can join the NCT07434479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Schizophrenia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07434479 currently recruiting?
Yes, NCT07434479 is actively recruiting participants. Contact the research team at anzalee.khan@nki.rfmh.org for enrollment information.
Where is the NCT07434479 trial being conducted?
This trial is being conducted at New York, United States, White Plains, United States.
Who is sponsoring the NCT07434479 clinical trial?
NCT07434479 is sponsored by Manhattan Psychiatric Center. The principal investigator is Anzalee Khan, PhD at Nathan Kline Institute for Psychiatric Research. The trial plans to enroll 58 participants.
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