A Virtual Reality Mindfulness Application for Aggression in Schizophrenia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorManhattan Psychiatric Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-Based Virtual Reality Intervention

    Other 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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Mindfulness-Based Virtual Reality (MBI-VR)Other 1 intervention
Group B: Distraction TasksOther 1 intervention

Trial outcomes

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)

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).

Sponsors and contacts

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Manhattan Psychiatric Center

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator