The benefits of being present: mindfulness and its role in psychological well-being.
Kirk Warren Brown, Richard M Ryan
https://pubmed.ncbi.nlm.nih.gov/12703651/Actively Recruiting
Led by Manhattan Psychiatric Center · Updated on 2026-06-10
58
Participants Needed
2
Research Sites
26 weeks
Total Duration
Researchers are evaluating whether a virtual reality-based mindfulness intervention can reduce impulsive aggression in individuals diagnosed with schizophrenia or schizoaffective disorder. The study aims to understand if mindfulness delivered through VR improves emotion regulation and activates the dorsomedial prefrontal cortex dmPFC, a brain area involved in controlling emotions. The trial also investigates whether the effects of this intervention relate to the dose received. Participants are randomly assigned to receive one of two doses of the mindfulness VR intervention 16 or 24 sessions or a non-immersive distraction control. The mindfulness sessions use the TRIPP VR platform with immersive, dynamic environments and guided exercises led by a virtual instructor. Distraction activities include listening to music, viewing images, or watching videos for a similar duration over six weeks. Brain activity is measured with functional MRI during an emotion regulation task at baseline, after 16 sessions, and after 24 sessions. Participants undergo clinical assessments at multiple points, including measures of aggression, impulsivity, mood, anxiety, quality of life, and mindfulness. Safety monitoring includes evaluating simulator sickness and suicide risk. The study collects behavioral data on aggression and medication use, and all assessments are repeated during the study to monitor changes. Participants continue their regular psychiatric care throughout the trial, which lasts approximately six weeks of intervention plus assessment periods.
CONDITIONS
A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
A
Anzalee Khan, PhD
B
Benedicto Parker
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Manhattan Psychiatric Center
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Mindfulness-Based VR Intervention | Distraction Tasks |
|---|---|---|
| What it is | A behavioral therapy program using virtual reality technology to deliver mindfulness-based interventions in supervised sessions. | An active control group where participants complete distraction activities, not focused on mindfulness skills. |
| Role in trial | Primary investigational intervention being evaluated for reducing aggression and impulsivity. | Active comparator designed to control for engagement and time, without specific mindfulness content. |
| Primary use | Studied as a behavioral intervention to reduce impulsive aggression in individuals with schizophrenia or schizoaffective disorder. | Serves as a non-mindfulness control to distinguish the effects of mindfulness training from generic distraction and engagement. |
| How it is given or performed | Delivered using a VR system with 10-minute sessions supervised by research staff. Participants interact with guided mindfulness content in a virtual environment. | Participants engage in distraction activities during supervised sessions, without mindfulness directions. |
| Evidence status | Effectiveness of VR mindfulness for aggression in schizophrenia is under investigation; similar interventions have shown promise for emotion regulation in related populations, but evidence in the specific trial context is limited. | Serves as an active control; distraction techniques have not been established as a core intervention for aggression in schizophrenia. |
| Important limitations | Long-term outcomes and effectiveness for aggression in schizophrenia remain unestablished; VR delivery can occasionally cause discomfort such as VR-related motion sickness. | Distraction approaches do not target underlying emotion regulation or mindfulness skills, and may have limited sustained impact on impulsive aggression. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive up to 24 sessions of either mindfulness-based virtual reality or non-immersive distraction activities over approximately 6 weeks. Sessions last about 10 minutes and include assessments of mood and anxiety.
Weekly visits for sessions and assessments
Duration - Throughout the study
Participants complete clinical and behavioral assessments, including brain imaging with fMRI at baseline, after 16 sessions, and after 24 sessions to evaluate changes in emotion regulation and aggression.
3 imaging sessions and weekly clinical assessments
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor