Schizophrenia DisorderNCT07434479
A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
A study testing Mindfulness-Based Virtual Reality Intervention in people with Schizophrenia Disorder and Schizoaffecitve Disorder, run by Manhattan Psychiatric Center at 2 sites in United States.
Trial summary
The study investigates whether a virtual reality-based mindfulness based intervention can reduce impulsive aggression in individuals with schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia Disorder, Schizoaffecitve Disorder, Aggression
- What is being tested?
- Mindfulness-Based Virtual Reality Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- TRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will:
- 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.
- 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).
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- Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR
- 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.
- Adult or late adolescent, between 18 and 64 years of age at the time of informed consent.
Who cannot join
- Participants will be excluded if they:
- 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
- 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)
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- 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)
- Score < 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003)
- Have a violent episode requiring seclusion, restraints, or a prn within the week before screening
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Manhattan Psychiatric Center
New York, New York, 10035
Naphtali Calliste, MPH, 646-766-5874, naphtali.calliste@nki.rfmh.org
Benedicto Parker, 212-961-8992, Benedicto.Parker@nki.rfmh.org
- Recruiting
NewYork-Presbyterian/Weill Cornell Medical Center Westchester Division
White Plains, New York, 10605
Jewel Bell, 914.682.5404, jeb4018@med.cornell.edu
Anthony Ahmed, PhD
About this study
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.
- Conditions
- Schizophrenia Disorder, Schizoaffecitve Disorder, Aggression
- Being tested
- Mindfulness-Based Virtual Reality Intervention
- Keywords
- mindfulness based intervention, schizophrenia, dmPFC, emotion regulation, impulsive aggression
- Medical subject headings
- Schizophrenia, Aggression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Virtual Reality InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Virtual Reality (MBI-VR) | Other | 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. Receives: Other: Mindfulness-Based Virtual Reality Intervention |
| Distraction Tasks | Other | 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. Receives: Other: Mindfulness-Based Virtual Reality Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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.
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
Secondary outcomes (7)
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.
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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).
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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.
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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.
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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.
Measured: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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.
Measured: 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.
Number and Type of Aggressive Incidents
Aggressive incidents will be collected from hospital medical records. Types of Aggressive Incidents
- Verbal Aggression: including yelling, cursing, threats of violence, and sexual harassment.
- Physical Assaults: These involve direct contact, such as hitting, kicking, punching, pushing, scratching, spitting, and biting.
- Other Incidents: This category includes damage to hospital property, armed incidents (such as guns or knives brought into the emergency department), and stalking.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start5 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, parallel-group, multicenter interventional clinical trial designed to evaluate the effects of a mindfulness-based virtual reality intervention (MBI VR) on impulsive aggression and neural target engagement in individuals with schizophrenia or schizoaffective disorder. The study compares two different doses of MBI VR with a non-immersive Distraction Techniques control condition. Following completion of screening and baseline assessments, eligible participants are randomized in a 1:1 ratio to one of two study arms: (1) MBI VR - 24 sessions/MBI VR - 16 sessions, or (2) Distraction Techniques control. Randomization is stratified by study site to ensure balance across treatment groups. Participants assigned to the MBI VR arms receive guided mindfulness training delivered via an immersive virtual reality platform. Sessions are conducted under supervision and last approximately 10 minutes each. The intervention is designed to promote attention regulation,
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manhattan Psychiatric Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Anzalee Khan, PhD, Principal investigator, Nathan Kline Institute for Psychiatric ResearchJean-Pierre Lindenmayer, MD, Study director, Nathan Kline Institute for Psychiatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434479
- Sponsor's protocol ID
- NKI2025-37-MPC
- Other IDs
- 1R61MH133785
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 30081863Hoptman 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 25900066Hoptman 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 25073506Fritz 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 33343427Flores 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 29740365Farb 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 20141299Davis 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<109::AID-HBM7>3.0.CO;2-W.
PubMed 10524601Cutcliffe 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 23750881Cohn 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 19545481Brown 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 12703651Aldao 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
- ClinicalTrials.gov ID
- NCT07434479
- Acronym / sponsor ID
- NKI2025-37-MPC
- Conditions
- Schizophrenia Disorder, Schizoaffecitve Disorder, Aggression
- Keywords
- mindfulness based intervention, schizophrenia, dmPFC, emotion regulation, impulsive aggression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Manhattan Psychiatric CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, parallel-group, multicenter interventional clinical trial designed to evaluate the effects of a mindfulness-based virtual reality intervention (MBI VR) on impulsive aggression and neural target engagement in individuals with schizophrenia or schizoaffective disorder. The study compares two different doses of MBI VR with a non-immersive Distraction Techniques control condition. Following completion of screening and baseline assessments, eligible participants are randomized in a 1:1 ratio to one of two study arms: (1) MBI VR - 24 sessions/MBI VR - 16 sessions, or (2) Distraction Techniques control. Randomization is stratified by study site to ensure balance across treatment groups. Participants assigned to the MBI VR arms receive guided mindfulness training delivered via an immersive virtual reality platform. Sessions are conducted under supervision and last approximately 10 minutes each. The intervention is designed to promote attention regulation,
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Virtual Reality (MBI-VR) | Other | Other: Mindfulness-Based Virtual Reality InterventionThe 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. |
| Distraction Tasks | Other | Other: Mindfulness-Based Virtual Reality InterventionTasks 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- TRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will:
- 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.
Key exclusion criteria (10 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Virtual Reality InterventionMBI 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. | Other | Distraction Tasks, Mindfulness-Based Virtual Reality (MBI-VR) |
Primary outcome
Short UPPS-P Impulsive Behavior Scale
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)
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.
Impulsive-Premeditated Aggression Scale
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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).
Positive and Negative Syndrome Scale
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
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.
7 secondary outcomes
Overt Aggression Scale - Modified
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
Clinical Global Impression Aggression Scales
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
Point Subtraction Aggression Paradigm
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
Quality-of-Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
Five-facet Mindfulness Questionnaire
Time frame: Baseline (Day 1), Week 4 (after 16 sessions), Week 6 (after 24 sessions)
Number of PRN Medications Issued for Aggressive Behavior
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.
Number and Type of Aggressive Incidents
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 30081863Klein 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.
- Background: PubMed 25900066Hoptman 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.
- Background: PubMed 25073506Hoptman 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.
- Background: PubMed 33343427Fritz 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.
- Background: PubMed 29740365Flores 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.
- Background: PubMed 20141299Farb 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.
- BackgroundDavis 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
- Background: PubMed 10524601Dale 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<109::AID-HBM7>3.0.CO;2-W.
- Background: PubMed 23750881Cutcliffe 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.
- BackgroundCohn 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.
- Background: PubMed 19545481Chadwick 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.
- Background: PubMed 12703651Brown 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anzalee Khan, PhD principal investigator
Nathan Kline Institute for Psychiatric Research
Jean-Pierre Lindenmayer, MD study director
Nathan Kline Institute for Psychiatric Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Virtual Reality Intervention in people with Schizophrenia Disorder and Schizoaffecitve Disorder, run by Manhattan Psychiatric Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anzalee Khan, PhD (646-766-5876, anzalee.khan@nki.rfmh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short UPPS-P Impulsive Behavior Scale (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434479, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.