RecruitingNot Applicable

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

United States58 participantsStarted 2026-03-02

Plain-language 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.

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Short UPPS-P Impulsive Behavior Scale

Timeframe: Will be conducted at Baseline (Day 1), Week 4 (after completion of 16 sessions of MBI-VR or Distraction Tasks), Week 6 (after completion of 24 sessions of MPV-VR or Distraction Tasks)

Impulsive-Premeditated Aggression Scale

Timeframe: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)

Positive and Negative Syndrome Scale

Timeframe: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)

Trial details

NCT IDNCT07434479

SponsorManhattan Psychiatric Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Anzalee Khan, PhD

646-766-5876 anzalee.khan@nki.rfmh.org

View on ClinicalTrials.gov More Schizophrenia Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Short UPPS-P Impulsive Behavior Scale

Timeframe: Will be conducted at Baseline (Day 1), Week 4 (after completion of 16 sessions of MBI-VR or Distraction Tasks), Week 6 (after completion of 24 sessions of MPV-VR or Distraction Tasks)

Impulsive-Premeditated Aggression Scale

Timeframe: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)

Positive and Negative Syndrome Scale

Timeframe: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria