Virtual Reality Treatment in a Methadone Maintenance Treatment Program for Chronic Pain and Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.
详细描述
The investigators will conduct a study of patients with co-morbid chronic pain and opioid use disorder enrolled in a methadone maintenance treatment program (MMTP) to pilot device feasibility and measure changes in pain intensity and opioid craving. All patients will be randomized to one of each of the following arms: 1) RelieVRx (intervention group) or 2) Non-immersive sham VR (control group).
The intervention being piloted is the RelieVRx - AppliedVR, Los Angeles, California - VR hardware and software. RelieVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.
RelieVRx is typically delivered in a 56-day program through daily virtual experiences, with each experience lasting between 2 and 16 minutes. In this pilot study, the investigators will conduct virtual experiences twice weekly at the MMTP. Over 6 weeks, participants in both groups will participate in 20-30 minute VR sessions twice per week. Each session will last about 20-30 minutes and go through 1-5 virtual experiences. The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx. Control participants will similarly experience 1-5 virtual experiences in each 20-30 session.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •English proficiency
- •receiving methadone treatment for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) confirmed Opioid Use Disorder (OUD) in the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability
- •chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale)
- •willingness to participate in all study components
- •ability to provide informed consent, assessed using consent teach-back
排除标准
- •conditions that could make participation in VR hazardous or cause adverse effects (current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines, any medical condition predisposing to nausea or dizziness, hypersensitivity to flashing light or motion)
- •conditions that could prevent proper use of the VR headset (stereoscopic vision or severe hearing impairment, or injury to eyes, face, or neck that prevents use of the VR headset)
- •acute exacerbation of psychiatric conditions that preclude the ability to participate in the study
结局指标
主要结局
Change in Pain Intensity
时间窗: From baseline to 6 weeks
Change in Pain Intensity from baseline was assessed using the single items Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Patients were asked to assess their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10 where 0 = no pain and 10 = worst pain imaginable. Positive mean scores were associated with increased pain intensity from baseline and negative mean scores were associated with decreased pain intensity from baseline. Scores were summarized by study arm using basic descriptive statistics.
Change in Opioid Craving
时间窗: From baseline to 6 weeks
Change in Opioid Craving was assessed using the Opioid Medication Craving Visual Analog Scale. This 3-item scale asked participants to rate how strong their desire to use opioids was during the previous 24 hours; the likelihood that they would use opioids if placed in the environment in which they had previously used drugs/alcohol; and how strong their urges for opioids are when something in their environment reminds them of it. Responses were marked on visual scale ranging from 0-100 where "0" signified 'No Desire or Likelihood of Use' and "100" signified 'Strong Desire or Likelihood of use. Positive mean scores were associated with increased opioid craving from baseline and negative mean scores were associated with decreased opioid craving from baseline. Scores were summarized by study arm using basic descriptive statistics.
Percentage of Participants Contacted That Are Enrolled
时间窗: Baseline, up to 2 weeks
The percentage of participants contacted who were enrolled into the study was used to assess the feasibility of the study. Results were summarized using basic descriptive statistics.
次要结局
- Change in Pain Interference(From baseline to 6 weeks)
- Change in Sleep(From baseline to 6 weeks)
- Change in Cognitive Function(From baseline to 6 weeks)
- Change in Social Function(From baseline to 6 weeks)
- Change in Physical Function(From baseline to 6 weeks)
- Change in Depression(From baseline to 6 weeks)
- Change in Anxiety(From baseline to 6 weeks)