58 Participants NeededMy employer runs this trial

Virtual Reality Mindfulness for Schizophrenia

Recruiting at 1 trial location
AK
BP
Overseen ByBenedicto Parker
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Manhattan Psychiatric Center
Must be taking: Atypical antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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 Is on the Research Team?

JL

Jean-Pierre Lindenmayer, MD

Principal Investigator

Nathan Kline Institute for Psychiatric Research

AK

Anzalee Khan, PhD

Principal Investigator

Nathan Kline Institute for Psychiatric Research

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Participants complete baseline clinical and behavioral assessments, including fMRI scans and plasma antipsychotic level measurements

1 week
1 visit (in-person)

Treatment

Participants receive up to 24 sessions of MBI VR or Distraction Techniques over a 6-week period, with neuroimaging and clinical assessments conducted at baseline, after 16 sessions, and after 24 sessions

6 weeks
24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of aggression, impulsivity, and quality of life

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-Based Virtual Reality Intervention

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Mindfulness-Based Virtual Reality (MBI-VR)Experimental Treatment1 Intervention
Group II: Distraction TasksExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Manhattan Psychiatric Center

Lead Sponsor

Trials
9
Recruited
1,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+