Virtual Reality Mindfulness for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if virtual reality mindfulness can help individuals with schizophrenia or schizoaffective disorder manage impulsive aggression. The researchers will test whether engaging with mindfulness in a virtual world can improve emotional control and activate the brain area involved in managing emotions. Participants will either experience varying doses of this Mindfulness-Based Virtual Reality Intervention or engage in distraction tasks, with brain activity measured to assess emotional regulation. This trial may suit someone with schizophrenia who is on stable medication and experiences impulsive aggression. As an unphased trial, this study offers a unique opportunity to explore innovative treatments and contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires participants to be on a stable dose of atypical antipsychotic medication for at least two weeks before joining. You won't need to stop your current medications if they meet this requirement.
What prior data suggests that this virtual reality-based mindfulness intervention is safe for individuals with schizophrenia or schizoaffective disorder?
Research has shown that using virtual reality for mindfulness exercises is generally safe for people with schizophrenia or schizoaffective disorder. One study found that any negative effects were minor and uncommon. Another study confirmed the safety of this approach for individuals with psychosis, including those with schizophrenia.
Additionally, previous research has found that virtual reality mindfulness can help people manage emotions and reduce stress and anxiety. This indicates that the treatment is not only safe but also beneficial in managing symptoms. Overall, it appears to be well-tolerated, with no serious side effects reported in the studies.12345Why are researchers excited about this trial?
Researchers are excited about the Mindfulness-Based Virtual Reality (MBI-VR) treatment for schizophrenia because it offers a novel approach by transforming mindfulness meditation into an immersive, interactive experience. Unlike traditional antipsychotic medications or cognitive behavioral therapy, MBI-VR uses visually dynamic environments and interactive elements to engage patients in a game-like setting, making the therapeutic process more engaging and potentially more effective. Additionally, the virtual instructor provides guided sessions with breathing techniques and body awareness exercises, offering a unique method for patients to manage symptoms and improve their mental health. This innovative use of virtual reality technology represents a fresh direction in schizophrenia treatment, with the potential to enhance patient engagement and outcomes.
What evidence suggests that this trial's treatments could be effective for schizophrenia?
This trial will compare a Mindfulness-Based Virtual Reality (MBI-VR) intervention with Distraction Tasks for individuals with schizophrenia. Research has shown that virtual reality for mindfulness exercises might benefit people with schizophrenia. Some studies suggest it can enhance mental health and increase mindfulness. Evidence also indicates it might help reduce impulsive aggression in these individuals. Although not all studies agree on its effectiveness compared to other treatments, most show some improvements without major negative effects. Overall, this type of treatment appears safe and worth further exploration.12678
Who Is on the Research Team?
Jean-Pierre Lindenmayer, MD
Principal Investigator
Nathan Kline Institute for Psychiatric Research
Anzalee Khan, PhD
Principal Investigator
Nathan Kline Institute for Psychiatric Research
Are You a Good Fit for This Trial?
This trial is for adults aged 18-64 with schizophrenia or schizoaffective disorder who have a history of impulsive aggression, are stable on their antipsychotic medication, can read and understand English, and have good vision and hearing. People with recent severe violence, unstable health, certain medical devices, or pregnancy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete baseline clinical and behavioral assessments, including fMRI scans and plasma antipsychotic level measurements
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of aggression, impulsivity, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness-Based Virtual Reality Intervention
Trial Overview
The study tests whether mindfulness exercises delivered through virtual reality (VR) can help reduce impulsive aggression in people with schizophrenia or schizoaffective disorder. Participants are randomly assigned to different amounts of VR mindfulness sessions or distraction tasks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The MBI VR is developed by TRIPP. Instead of naturalistic scenic images, the TRIPP MBI VR features intricate visually dynamic environments such as colorful surreal landscapes, light-based effects, floating shapes and immersive spatial soundscapes. These visuals encourage participants to focus on flowing designs, fostering a sense of engagement. The game-like quality of the virtual environment includes interactive elements where participants can manipulate shapes or respond to stimuli. This interactivity can enhance engagement, turning mindfulness meditation into a game-like playful and exploratory experience. The TRIPP MBI VR program offers guided sessions led by a virtual instructor, who provides verbal cues and instructions for the practice. This guidance includes breathing techniques, body awareness exercises, or instructions for focusing attention.
Tasks will include standard rehabilitative inpatient treatment as usual (TAU) which includes wellness and recovery sessions, coping skills, understanding medications, discharge preparation, and behavioral sessions and Distraction Techniques. Distraction Techniques that encompass activities designed to engage participants and divert their attention from discomfort or distressing thoughts. These techniques can include: 1. Listening to Music: Participants may listen to calming or enjoyable music, which can help reduce anxiety and enhance relaxation by promoting positive emotional states. 2. Viewing Images: Participants may look at carefully selected images or visuals, such as nature scenes, art, or other soothing imagery. This can create a sense of calm and provide a mental escape from their current situation. 3. Watching Videos: Participants may engage with short videos or clips that are designed to be engaging, aiming to promote distraction and engage their interest.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Manhattan Psychiatric Center
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
NCT05784948 | Safety and Efficacy of Virtual Reality ...
This study is randomized, single-blind and parallel group trial to evaluate the safety and the efficacy of Virtual Reality Mindfulness in Patients With ...
The effectiveness of immersive virtual reality (VR) based ...
The aim of this study is to investigate whether VR-based mindfulness training can improve mental health outcomes, and notably mindfulness levels amongst adults.
Effects and safety of virtual reality-based mindfulness in ... - PMC
These results suggest that VBM was not more effective in reducing decentering and psychiatric symptoms than VR control but its adversity was modest.
The effects of mindfulness-based training in virtual reality ...
Our study indicates good feasibility of the developed mindfulness intervention in VR in schizophrenic patients. The results indicate potential benefits in terms ...
The role of mindfulness training supported by virtual reality in ...
This paper presents the outcome of a clinical trial planning process developed during multicenter, multidisciplinary seminars with ...
Effects of virtual reality technology on core symptoms ...
Virtual reality (VR) has been increasingly applied in psychiatric rehabilitation and shows promise for improving outcomes in schizophrenia.
7.
researchgate.net
researchgate.net/publication/374026816_Effects_and_safety_of_virtual_reality-based_mindfulness_in_patients_with_psychosis_a_randomized_controlled_pilot_studyEffects and safety of virtual reality-based mindfulness in ...
We investigated safety and effects of virtual reality-based mindfulness (VBM) in patients with psychosis as a pilot study. Sixty-four patients ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-virtual-reality-mindfulness-application-for-aggression-in-schizophreniaA Virtual Reality Mindfulness Application for Aggression in ...
The study investigates whether a virtual reality-based mindfulness based intervention can reduce impulsive aggression in individuals with ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.