A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Short UPPS-P Impulsive Behavior Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •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.
排除标准
- •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)
- •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.
研究组 & 干预措施
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:
- Listening to Music: Participants may listen to calming or enjoyable music, which can help reduce anxiety and enhance relaxation by promoting positive emotional states.
- 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.
- Watching Videos: Participants may engage with short videos or clips that are designed to be engaging, aiming to promote distraction and engage their interest.
干预措施: Mindfulness-Based Virtual Reality Intervention (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.
干预措施: Mindfulness-Based Virtual Reality Intervention (Other)
结局指标
主要结局
Short UPPS-P Impulsive Behavior Scale
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Number of PRN Medications Issued for Aggressive Behavior(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(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.)