A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

NCT07434479 | Recruiting DMC

• 2 other identifiers: NKI2025-37-MPC1R61MH133785
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia Disorder; Schizoaffecitve Disorder; Aggression

Keywords

mindfulness based intervention; schizophrenia; dmPFC; emotion regulation; impulsive aggression

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

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

Secondary Outcomes (7)

• Overt Aggression Scale - Modified

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

• Clinical Global Impression Aggression Scales

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

• Point Subtraction Aggression Paradigm

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

• Quality-of-Life Enjoyment and Satisfaction Questionnaire - Short Form

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

• Five-facet Mindfulness Questionnaire

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

Other Outcomes (9)

• Oxford Daily Mood Scale (OMS)

  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.

• Columbia-Suicide Severity Rating Scale Baseline

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

• Columbia-Suicide Severity Rating Scale Since Last Visit

  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.

Study Arms (2)

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.

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.

Other: Mindfulness-Based Virtual Reality Intervention

Interventions

Mindfulness-Based Virtual Reality Intervention OTHER

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.

Distraction Tasks; Mindfulness-Based Virtual Reality (MBI-VR)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Manhattan Psychiatric Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

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

Related Publications (13)

• 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.

  PMID: 30081863 BACKGROUND

• 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.

  PMID: 25900066 BACKGROUND

• 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.

  PMID: 25073506 BACKGROUND

• 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.

  PMID: 33343427 BACKGROUND

• 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.

  PMID: 29740365 BACKGROUND

• 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.

  PMID: 20141299 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 10524601 BACKGROUND

• 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.

  PMID: 23750881 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19545481 BACKGROUND

• 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.

  PMID: 12703651 BACKGROUND

• 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.

  PMID: 20015584 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Aggression; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Self-Control

Study Officials

• Anzalee Khan, PhD

  Nathan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

• Jean-Pierre Lindenmayer, MD

  Nathan Kline Institute for Psychiatric Research

  STUDY DIRECTOR

Central Study Contacts

Anzalee Khan, PhD

CONTACT

646-766-5876; anzalee.khan@nki.rfmh.org

Benedicto Parker

CONTACT

212-961-8992; Benedicto.Parker@nki.rfmh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical team assessments will be done by the clinical team, independent from the research assessments. Raters who are completing assessments examining aggression and impulsive aggression including the PANSS, S-UPPS-P, OAS-M, CGI-S Aggression, CGI-I Aggression, IPAS, and PSAP will be blinded to the treatment assignment. To ensure blinding of these raters, the following will be done: Raters administering and scoring assessments will be independent from the team delivering the treatment or intervention (e.g., VR mindfulness or distraction condition). They will have no access to information about treatment assignments or session content. Communications with participants will avoid mentioning any content or terms that might reveal group assignment. Treatment assignment will be coded and stored separate from assessment data in a secure system accessible only to unblinded study personnel. Raters will only receive Participant ID numbers and will not have access to group assign
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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,

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 25, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-01

Locations

US (2)