A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorManhattan Psychiatric Center
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Have past head trauma
Diagnosed with a neurological disorder
Are pregnant or breastfeeding women as evidenced by the participant's medical record.
Have unstable medical illness that compromises the safety of the patient
Trial design
Treatments tested in this trial
- Mindfulness-Based Virtual Reality Intervention
Treatment groups
58 Participants
are divided into 2 treatment groupsSponsors and collaborators
Manhattan Psychiatric Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov