ClinicalTrials.gg
RecruitingNCT07434479Updated Jun 10, 2026

A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

An interventional study of Mindfulness-Based Virtual Reality Intervention in Schizophrenia Disorder, Schizoaffecitve Disorder and Aggression, sponsored by Manhattan Psychiatric Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Manhattan Psychiatric Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the detailed description

This is a randomized, parallel-group, multicenter clinical trial designed to evaluate the effects of a mindfulness-based virtual reality intervention (MBI VR) on impulsive aggression and associated neural target engagement in individuals with schizophrenia or schizoaffective disorder. The study compares two different doses of MBI VR (16 sessions vs. 24 sessions) to a non-immersive Distraction Techniques control condition. Neural target engagement is assessed via functional magnetic resonance imaging (fMRI), with a focus on activation of the dorsomedial prefrontal cortex (dmPFC) during an emotion regulation task.

Screening and Baseline Procedures

Potential participants are identified through a structured pre-screening process involving review of electronic and paper medical records to assess demographic eligibility, psychiatric diagnosis, aggression history, medication adherence, and medical suitability for MRI procedures. Individuals meeting preliminary eligibility criteria are approached for informed consent.

At the Screening Visit, participants undergo diagnostic confirmation using the SCID-5-RV, assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS Baseline), review of medication adherence, and evaluation of impulsive aggression history using the Impulsive-Premeditated Aggression Scale (IPAS). Inclusion and exclusion criteria are confirmed through clinical interview, collateral information, and medical record review.

Eligible participants complete baseline clinical and behavioral assessments, including measures of aggression, impulsivity, psychopathology, mood, anxiety, quality of life, and mindfulness (as applicable). Baseline plasma antipsychotic levels are obtained to assess medication adherence and reduce pharmacologic confounding. Participants also complete a baseline fMRI scan at the Nathan S. Kline Institute for Psychiatric Research.

Randomization and Study Arms

Following completion of baseline procedures, participants are randomized using a stratified randomization approach to ensure balance across treatment arms and study sites. Participants are assigned to one of the following groups:

Mindfulness-Based Intervention Virtual Reality (MBI VR) Distraction Techniques Control

All participants receive up to 24 sessions of their assigned intervention. Neuroimaging and clinical assessments are conducted at baseline, after completion of 16 sessions, and after completion of 24 sessions.

Mindfulness-Based Intervention Virtual Reality (MBI VR)

Participants randomized to the MBI VR group engage in guided mindfulness sessions delivered via the TRIPP™ virtual reality platform using a head-mounted display (Meta Quest 3). Each session lasts approximately 10 minutes and is conducted under supervision of trained research staff.

At the beginning of each session, participants rate their current mood and anxiety using the Oxford Daily Mood Scale (OMS) and State-Trait Anxiety Inventory (STAI). These assessments are administered within the VR environment, with selections made using gaze-based interaction.

The TRIPP MBI VR experience places participants in immersive, computer-generated environments designed to promote relaxation, attentional focus, and emotional awareness. Environments consist of visually dynamic and abstract landscapes, light-based effects, and immersive spatial audio rather than realistic scenes. Guided mindfulness exercises are delivered by a virtual instructor and include breathing awareness, focused attention, body awareness, visualization meditation, and nonjudgmental observation of thoughts and emotions.

Participants are prompted to synchronize breathing with visual cues (e.g., expanding and contracting shapes), reinforcing interoceptive awareness and attentional regulation. Interactive elements are incorporated to enhance engagement while maintaining a non-competitive, exploratory experience. Ambient soundscapes and music are used to support relaxation and sustained attention.

At the conclusion of each session, participants again complete the OMS and STAI to assess immediate changes in mood and anxiety. Participants are encouraged to reflect briefly on their experience, similar to reflective components used in non-VR mindfulness interventions.

All VR sessions are managed via a mobile device management system that allows real-time monitoring and data collection. Research staff remain present to assist with equipment setup and to pause or discontinue sessions if participants experience discomfort or distress.

Distraction Techniques Control Condition

Participants randomized to the Distraction Techniques group engage in non-immersive distraction activities for approximately 10 minutes per session over the same 6-week period. Activities include listening to music, viewing images, or watching brief video clips selected to be engaging but not mindfulness-based.

Participants in this group receive treatment as usual (TAU) in the inpatient setting, including standard rehabilitative programming. The Distraction Techniques condition is designed to control for time, attention, and engagement while isolating the specific effects of immersive mindfulness training delivered via VR.

Functional Magnetic Resonance Imaging (fMRI)

All participants undergo fMRI scanning at three time points: baseline, after 16 sessions, and after 24 sessions. Scans are conducted at the Nathan S. Kline Institute for Psychiatric Research using a 3T Siemens Tim Trio scanner with a 32-channel head coil.

During each scan, participants complete a validated emotion regulation task adapted from Foti and Hajcak (2008). The task involves viewing neutral and unpleasant images from the International Affective Picture System (IAPS), preceded by auditory descriptions that either encourage emotional reactivity or cognitive reappraisal. Participants practice the task outside the scanner prior to imaging to ensure comprehension.

The primary contrast of interest compares unpleasant images preceded by negative versus neutral descriptions, providing an index of emotion regulation. Activation of the dorsomedial prefrontal cortex (dmPFC) during this contrast serves as the primary neural target engagement outcome.

Participants are not scanned within 24 hours of receiving PRN medications to minimize sedation effects. Transport to imaging sessions is conducted with hospital and research staff accompaniment to ensure safety.

Clinical and Behavioral Assessments

Clinical assessments are conducted at screening, baseline, weekly during the intervention period, and at post-intervention time points. Assessments include clinician-rated measures of aggression, psychopathology, and global clinical change, as well as self-report measures of impulsivity, mood, anxiety, quality of life, and mindfulness (MBI VR group only).

Aggression-related assessments include the IPAS, S-UPPS-P, OAS-M, PANSS (including PANSS Excitement Component), CGI-S and CGI-I Aggression, Point Subtraction Aggression Paradigm (PSAP), and real-world behavioral data (e.g., incidents, PRN use, restraints). Suicide risk is monitored throughout the study using the C-SSRS.

Raters conducting aggression and psychopathology assessments are blinded to treatment assignment. Wherever possible, the same rater evaluates a participant throughout the study to reduce inter-rater variability.

Safety Monitoring and Tolerability

Adverse events, including simulator sickness and distress related to VR exposure, are monitored throughout the study. The Simulator Sickness Questionnaire (SSQ) is administered following VR exposure. A score of ≥30 on the SSQ is considered indicative of intolerance and constitutes a criterion for withdrawal from VR participation.

Participants may discontinue participation at any time without impact on their standard psychiatric care. All participants continue to receive treatment as usual for schizophrenia or schizoaffective disorder throughout the study.

02

Conditions studied

  • Schizophrenia Disorder
  • Schizoaffecitve Disorder
  • Aggression

Keywords

  • mindfulness based intervention
  • schizophrenia
  • dmPFC
  • emotion regulation
  • impulsive aggression
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 58 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Manhattan Psychiatric Center is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

TRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will:

  1. Is willing and able to provide written to participate in the study, attend study visits, and comply with study-related requirements and assessments.
  2. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
  3. Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment.
  4. 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.
  5. 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).
  6. Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR
  7. 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.
  8. Adult or late adolescent, between 18 and 64 years of age at the time of informed consent.

Exclusion criteria

Exclusion Criteria:

Participants will be excluded if they:

  1. Have past head trauma
  2. Diagnosed with a neurological disorder
  3. Are pregnant or breastfeeding women as evidenced by the participant's medical record.
  4. Have unstable medical illness that compromises the safety of the patient
  5. Have significant suicidal ideation at screening (as assessed by the Columbia - Suicide Severity Rating Scale (C-SSRS; participant answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS; Non-suicidal self-injurious behavior is not exclusionary)
  6. Are on Electroconvulsive therapy (ECT) within 6 months of the study, participants with metal in their bodies or who have claustrophobia or who do not pass the criteria in NKI's Magnetic Resonance Safety Questionnaire (MRSQ)
  7. Score \< 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003)
  8. Have a violent episode requiring seclusion, restraints, or a prn within the week before screening
  9. Evidence of suboptimal medication adherence in the 2 weeks prior to enrollment, as determined by electronic medication records review, and demonstrated by prescriber reported non- adherence to prescribed schedule. Suboptimal adherence includes missed doses (two of more missed doses within the past 2 weeks) or plasma levels indicating that the participant is not receiving the intended therapeutic dose.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (estimated)

Study arms

  • Other
    Mindfulness-Based Virtual Reality (MBI-VR)

    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.

    Other: Mindfulness-Based Virtual Reality Intervention

  • Other
    Distraction Tasks

    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.

    Other: Mindfulness-Based Virtual Reality Intervention

Interventions

  • OtherMindfulness-Based Virtual Reality Intervention

    MBI VR is managed through a mobile device management (MDM) solution that supports full access remotely, to ensure the real-time data collection. Research staff members will be available at each session to assist with operational aspects of the MBI VR program (e.g., setting up the VR system, pausing the system if the participant expresses discomfort or distress). MBI delivered via VR is generally considered to be well-tolerated (Dascal et a., 2017); therefore, we do not expect any significant adverse events to occur. However, any seasickness-type of sensation can last for a few hours and even up to a week depending on many factors. While some people rarely experience VR motion sickness, others may continuously suffer symptoms of motion sickness for weeks. The most important factor is the extent of time of uninterrupted exposure. In the present study the exposure is 10 minutes, which is not expected to cause significant VR motion sickness.

06

What researchers measure

Primary outcomes

  1. Short UPPS-P Impulsive Behavior Scale

    The Short UPPS-P is an instrument composed of 20 items rated on a four-point Likert scale: (1) disagree strongly, (2) disagree some, (3) agree some, and (4) agree strongly. Five scales were computed by adding the 4 items corresponding to each scale: (1) negative urgency (NU), the tendency to act impulsively when experiencing negative emotions (e.g., sadness, anger); (2) positive urgency (PU), the tendency to act rashly under extreme positive emotions or excitement; (3) sensation seeking (SS), the tendency to seek out novel and thrilling experiences, often involving risk; (4) lack of perseveration (PE), the inability to stay focused on a task, especially when it becomes difficult or boring; and (5) lack of premeditation (PR), difficulty thinking and reflecting on the consequences of an act before engaging in it. Each scale ranges from 4 to 16.

    Time frame: 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)

  2. Impulsive-Premeditated Aggression Scale

    The Impulsive-Premeditated Aggression Scale (IPAS; Mathias et al., 2007) will be administered at screening, baseline, after completion of 16 sessions and after completion of 24 sessions. The IPAS is a 30-item self-report questionnaire used to rate aggressive acts occurring over the past six months. Items are scored on a five-point scale (1 = Strongly Disagree; 2 = Disagree; 3 = Neutral; 4 = Agree; 5 = Strongly Agree). The scale differentiates three factors -premeditated aggression, here referred to as 'PM' and impulsive aggression, here referred to as 'IA'-that can be scored either dimensionally or categorically, and Familiarity Items (Stanford MS, Classification procedures, unpublished manual). Discrete categories (impulsive vs premeditated) are obtained by a categorical approach in which only the percentage of the positive items (5 = strongly agree or 4 = agree) for each aggression scale is calculated (Stanford MS, Classification procedures, unpublished manual).

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

  3. Positive and Negative Syndrome Scale

    The PANSS will be used to assess psychopathology. The PANSS is a 30-item, clinician-administered assessment that provides scores for positive, negative, and general psychopathology symptoms. The PANSS Excitement Component (PANSS EC; Lindenmayer et al., 2004a; Faay et al., 2018, Lindenmayer et al., 2004b, Montoya et al., 2011) will be examined to assess change in aggressive behaviors. Each PANSS item is scored from 1 to 7, with a minimum score of 30 and a maximum score of 210.

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

Secondary outcomes

  1. Overt Aggression Scale - Modified

    Our secondary outcome measure is time to aggressive acts as measured by the Overt Aggression Scale - Modified (OAS-M). The OAS-M is a four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes: verbal aggression, aggression against objects, aggression against self, and aggression against others. The OAS-M is a widely used measures for violence and aggression (Mattes, 2010). Each category is rated 0-4 based on severity, with the score multiplied by a weight (1, 2, 3, or 4, respectively) to produce a total weighted score.

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

  2. Clinical Global Impression Aggression Scales

    The CGI rating scales are tools used to evaluate both the severity of illness and change from baseline (Guy 1976). The CGI-S Aggression reflects the severity of illness on a 7-point scale ranging from no symptoms (1) to very severe (7). The CGI-I Aggression is used to assess the clinical change as compared to symptoms at baseline using a 7-point scale, ranging from very much improved (1) to very much worse (7).

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

  3. Point Subtraction Aggression Paradigm

    The PSAP is a commonly used behavioral aggression paradigm wherein participants earn points (i.e., money) and can steal points from (i.e., aggressive behavior) or have points stolen by an opponent (i.e., provocation), reflecting a more social/non-violent form of reactive aggression. Aggression is scored by counting the number of button presses (e.g., 40, 50, or 100) on a "provocation" button that removes points from the opponent, or by total point subtractions per trial.

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

  4. Quality-of-Life Enjoyment and Satisfaction Questionnaire - Short Form

    The QLES-Q-SF will be administered at each study visit to measure patient-assessed health and well-being. This brief, self-report measure is made up of 16 items and is scored using a 5-point Likert scale, and the higher the total score, the more satisfied the patient is with life. The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) is a 16-item self-report tool where the first 14 items are summed to measure life satisfaction (scores 14-70), with higher scores indicating greater enjoyment. Items use a 5-point Likert scale (1=Very Poor, 5=Very Good). It is converted to a 0-100% scale for interpretation.

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

  5. Five-facet Mindfulness Questionnaire

    The Five-facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006) is a 15 question self-report scale that measures mindfulness with regards to thoughts, experiences, and actions in daily life. The FFMQ-15 measures 5 subscales of mindfulness: Observing, Describing, Acting with Awareness, Non-judgement, and Non-reactivity. The FFMQ will only be completed by participants who are assigned to the MBI VR Group. The self-report scale scored on a 1-5 Likert scale (1=Never true, 5=Very often true). It measures five facets of mindfulness by summing item scores, with some items reverse-scored to indicate higher mindfulness with higher total scores.

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

  6. Number of PRN Medications Issued for Aggressive Behavior

    The metric measures the total count of "pro re nata" (PRN) or "as needed" medications administered to a patient in response to acts of physical violence, verbal aggression, or extreme agitation. It is used to monitor behavioral stability, evaluate the effectiveness of non-pharmacological interventions, and ensure safety against over-sedation or misuse.

    Time frame: The number of PRN medications will be collected from 3 months prior to Baseline (Day 1), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6.

  7. Number and Type of Aggressive Incidents

    Aggressive incidents will be collected from hospital medical records. Types of Aggressive Incidents 1. Verbal Aggression: including yelling, cursing, threats of violence, and sexual harassment. 2. Physical Assaults: These involve direct contact, such as hitting, kicking, punching, pushing, scratching, spitting, and biting. 3. Other Incidents: This category includes damage to hospital property, armed incidents (such as guns or knives brought into the emergency department), and stalking.

    Time frame: Number and Type of Assaultive Incidents will be collected 3 months prior to Baseline (Day 1), Baseline (Day 1), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6.

Other outcomes

  1. Oxford Daily Mood Scale (OMS)

    The Oxford Daily Mood Scale is a self-assessment tool designed to help individuals quantify their emotional state throughout the day using a simple 10-point scale. This scale allows users to track fluctuations in their mood over time by assigning a score based on how they felt at different points during the day. Scale Description: 1. Very Depressed 2. Depressed 3. Somewhat Low 4. Slightly Low 5. "So-so" 6. Slightly Good 7. Somewhat Happy 8. Happy 9. Very Happy

    Time frame: The Oxford Mood Scale is done prior to the start of each MBI VR or Distraction Techniques sessions at Baseline (Day 1), Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6.

  2. Columbia-Suicide Severity Rating Scale Baseline

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical tool designed to assess suicide risk, facilitating comprehensive evaluations in both clinical and research settings. Below is an extended description of the scale, its application, and its significance in assessing suicide risk. The C-SSRS aims to: Identify Individuals at Risk: It helps health professionals determine the severity of suicidal ideation and behavior in individuals, enabling timely intervention. Facilitate Management Plans: By quantifying suicide risk, this scale informs treatment planning and follow-up strategies. Standardize Assessments: It provides a structured format for evaluating suicidality, enhancing reliability across different raters and settings.

    Time frame: The C-SSRS Baseline version will be completed at Baseline (Day 1) for all study participants.

  3. Columbia-Suicide Severity Rating Scale Since Last Visit

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical tool designed to assess suicide risk, facilitating comprehensive evaluations in both clinical and research settings. Below is an extended description of the scale, its application, and its significance in assessing suicide risk. The C-SSRS aims to: Identify Individuals at Risk: It helps health professionals determine the severity of suicidal ideation and behavior in individuals, enabling timely intervention. Facilitate Management Plans: By quantifying suicide risk, this scale informs treatment planning and follow-up strategies. Standardize Assessments: It provides a structured format for evaluating suicidality, enhancing reliability across different raters and settings.

    Time frame: The C-SSRS Since Last Visit version is completed once a week at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6.

  4. Simulator Sickness Questionnaire

    The Simulator Sickness Questionnaire (SSQ) is a 16-item self-report tool developed by Kennedy et al. (1993) to quantify side effects from virtual environments or flight simulators. It rates symptoms - nausea, oculomotor, and disorientation, on a 0-3 scale, widely used to assess cybersickness in VR. Scores determine overall severity, aiding in identifying problematic simulators. The SSQ measures 16 symptoms (e.g., headache, eyestrain, dizziness, vertigo, nausea) rated by the participant as "None" (0), "Slight" (1), "Moderate" (2), or "Severe" (3). Subscales: Symptoms are grouped into three factors: 1. Nausea (N): General discomfort, increased salivation, sweating, nausea, difficulty concentrating, stomach awareness, burping. 2. Oculomotor (O): General discomfort, fatigue, headache, eyestrain, difficulty focusing, difficulty concentrating, blurred vision. 3\. Disorientation (D): Difficulty focusing, nausea, fullness of head, blurred vision, dizziness, vertigo.

    Time frame: The Simulator Sickness Questionnaire is administered after the participant has completed each MBI VR session at each visit (Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6).

  5. Structured Clinical Interview for DSM-5 (SCID-5) - Research Version

    The SCID-5-RV (Research Version) is a specialized adaptation of the Structured Clinical Interview for DSM-5 (SCID-5) designed specifically for use in clinical trials. This version has been reformatted, streamlined, and optimized to meet the requirements of clinical research protocols. The SCID-5 is primarily designed to ensure that major psychiatric diagnoses, as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM- 5), are systematically evaluated.

    Time frame: The SCID-5-RV will be completed at Screening to confirm diagnosis.

  6. Mobile App Rating Scale

    The Mobile App Rating Scale (MARS) is a reliable, multidimensional tool designed to assess the quality of mobile health (mHealth) apps across 23 items covering engagement, functionality, aesthetics, information quality, and subjective impact. It uses a 5-point scale (1-inadequate to 5-excellent) to evaluate apps, making it a standard instrument for researchers and developers to ensure high-quality, evidence-based app development. The MARS includes the following dimensions: 1. Assesses apps based on Engagement (fun, interest), 2. Functionality (performance, navigation), 3. Aesthetics (layout, graphics), and 4. Information Quality (accuracy, evidence base).

    Time frame: The MARS is completed at Week 24 or Early Termination Visits.

  7. Antipsychotic Plasma Levels

    In order to ascertain medication adherence and to minimize confounding effects of antipsychotic medication treatment, we will measure antipsychotic plasma level at baseline, and after 16 and 24 sessions.

    Time frame: Measurements of antipsychotic plasma level will be taken at Baseline (Day 1), Week 4 and Week 6.

  8. Number of seclusion or restraints related to aggressive behaviors

    Seclusion and restraint are last-resort safety measures for imminent, severe aggression or self-injury, not for punishment or convenience. They involve involuntary confinement or physical/mechanical restriction of movement. These practices carry risks of serious injury, trauma, and, in rare cases, fatality, requiring strict, immediate oversight. The number of times a participant was restrained or secluded will be collected.

    Time frame: The number of seclusions and restraints will be collected from 3 months prior to Baseline (Day 1) and at Baseline (Day 1), Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6.

  9. Number and Type of Arrests

    "Number and Type of Arrests" measures the volume and nature of law enforcement apprehensions. It will be used to track the total count of crimes committed, as one incident may result in multiple arrests or vice versa. The following will be collected: 1. Total Volume: The aggregate count of all arrests made, 2. Type of Offense (i.e., Group A Offenses: includes violent crimes (homicide, rape, robbery, aggravated assault), property crimes (burglary, larceny, motor vehicle theft, arson), and drug offenses; Group B Offenses: Crimes for which only arrest data are reported, such as disorderly conduct, DUI, drunkenness, and vagrancy).

    Time frame: The number and type of arrests will be collected from 3 months prior to Baseline (Day 1) and at Baseline (Day 1), Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6.

07

Study locations

2 of 2 sites recruiting
  • Manhattan Psychiatric Center
    New York, New York 10035, United States
    Recruiting
  • NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division
    White Plains, New York 10605, United States
    Recruiting
08

References and documents

Publications

  • Klein Tuente S, Bogaerts S, van IJzendoorn S, Veling W. Effect of virtual reality aggression prevention training for forensic psychiatric patients (VRAPT): study protocol of a multi-center RCT. BMC Psychiatry. 2018 Aug 6;18(1):251. doi: 10.1186/s12888-018-1830-8. PubMed 30081863 ↗
  • Hoptman MJ. Impulsivity and aggression in schizophrenia: a neural circuitry perspective with implications for treatment. CNS Spectr. 2015 Jun;20(3):280-6. doi: 10.1017/S1092852915000206. Epub 2015 Apr 22. PubMed 25900066 ↗
  • Hoptman MJ, Antonius D, Mauro CJ, Parker EM, Javitt DC. Cortical thinning, functional connectivity, and mood-related impulsivity in schizophrenia: relationship to aggressive attitudes and behavior. Am J Psychiatry. 2014 Sep;171(9):939-48. doi: 10.1176/appi.ajp.2014.13111553. PubMed 25073506 ↗
  • Fritz M, Shenar R, Cardenas-Morales L, Jager M, Streb J, Dudeck M, Franke I. Aggressive and Disruptive Behavior Among Psychiatric Patients With Major Depressive Disorder, Schizophrenia, or Alcohol Dependency and the Effect of Depression and Self-Esteem on Aggression. Front Psychiatry. 2020 Dec 3;11:599828. doi: 10.3389/fpsyt.2020.599828. eCollection 2020. PubMed 33343427 ↗
  • Flores A, Linehan MM, Todd SR, Hoffman HG. The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Spinal Cord Injury: A Case Study. Front Psychol. 2018 Apr 23;9:531. doi: 10.3389/fpsyg.2018.00531. eCollection 2018. PubMed 29740365 ↗
  • Farb NA, Anderson AK, Mayberg H, Bean J, McKeon D, Segal ZV. Minding one's emotions: mindfulness training alters the neural expression of sadness. Emotion. 2010 Feb;10(1):25-33. doi: 10.1037/a0017151. PubMed 20141299 ↗
  • Davis L, Kurzban S. Mindfulness-based treatment for people with severe mental illness: a literature review. American Journal of Psychiatric Rehabilitation. 2012;15(2):202-232.doi:10.1080/15487768.2012.679578
  • Dale AM. Optimal experimental design for event-related fMRI. Hum Brain Mapp. 1999;8(2-3):109-14. doi: 10.1002/(SICI)1097-0193(1999)8:2/3&#x0003c;109::AID-HBM7&#x0003e;3.0.CO;2-W. PubMed 10524601 ↗
  • Cutcliffe JR, Riahi S. Systemic perspective of violence and aggression in mental health care: towards a more comprehensive understanding and conceptualization: part 1. Int J Ment Health Nurs. 2013 Dec;22(6):558-67. doi: 10.1111/inm.12029. Epub 2013 Jun 11. PubMed 23750881 ↗
  • Cohn AM, Jakupcak M, Seibert LA, Hildebrandt TB, Zeichner A. The role of emotion dysregulation in the association between men's restrictive emotionality and use of physical aggression. Psychology of Men & Masculinity. 2010;11(1):53.
  • Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23. PubMed 19545481 ↗
  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822. PubMed 12703651 ↗
  • Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20. PubMed 20015584 ↗

Individual participant data

Plan to share: Undecided — Individual Participant Data (IPD) will not be shared to protect participant privacy and confidentiality, given the sensitive nature of the clinical, behavioral, and neuroimaging data collected in this study. The dataset includes detailed mental health assessments, aggression-related measures, and brain imaging data, which pose a risk of re-identification even after de-identification. In addition, participants did not provide consent for broad data sharing beyond the scope of the study. Therefore, to comply with ethical standards, informed consent agreements, and applicable privacy regulations, IPD will not be made publicly available.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 12 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2026
First posted
Feb 25, 2026
StartEst.
Jun 5, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07434479
Lead sponsor
Manhattan Psychiatric Center
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Jun 5, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Anzalee Khan, PhD
Contact
anzalee.khan@nki.rfmh.org
646-766-5876
Benedicto Parker
Contact
Benedicto.Parker@nki.rfmh.org
212-961-8992
Anzalee Khan, PhD
principal investigator · Nathan Kline Institute for Psychiatric Research
Jean-Pierre Lindenmayer, MD
study director · Nathan Kline Institute for Psychiatric Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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