Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

Study Overview
=================
Brief Summary
-----------------
This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.

Detailed Description
-----------------
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, CA - 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.

Official Title
-----------------
Virtual Reality Treatment in a Methadone Maintenance Treatment Program for Chronic Pain and Opioid Use Disorder

Conditions
-----------------
Chronic Pain, Opioid Use Disorder

Intervention / Treatment
-----------------
* Device: RelieVRx
* Device: Sham VR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RelieVRx<br>RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. | Device: RelieVRx<br>* The virtual reality device that will be piloted is called RelieVRx, which 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.<br>|
| Sham Comparator: Sham Virtual Reality<br>The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. | Device: Sham VR<br>* The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity | The investigators will use the Pain, Enjoyment of Life and General Activity scale (scored 1-10) to measure change in pain intensity. Higher scores indicate greater pain intensity. | baseline, 6 weeks | 
| Change in Opioid Craving | The investigators will use the Opioid Craving Visual Analog Scale (scored 0-100) to measure opioid craving. Higher scores indicate greater opioid craving. | baseline, 6 weeks | 
| Percent of participants contacted that are enrolled | The investigators will determine feasibility by measuring the percentage of participants that are contacted who are enrolled. | baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference | The investigators will use the Patient-Reported Outcomes Measurement Information System Pain Intensity Subscale to measure change in pain intensity. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates greater pain interference. | baseline, 3 weeks, 6 weeks | 
| Change in Sleep | The investigators will use the Patient-Reported Outcomes Measurement Information System Short Form 6a to assess changes in sleep. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates higher sleep quality. | baseline, 3 weeks, 6 weeks | 
| Change in Opioid Prescription | The investigators will use Prescription Monitoring Program (PMP) records to assess changes in participants' opioid prescriptions. | baseline, 3 weeks, 6 weeks | 
| Change in Cognitive Function | The investigators will use the Patient-Reported Outcomes Measurement Information Cognitive Function to assess changes in cognitive function. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates greater impairments in cognitive function. | baseline, 3 weeks, 6 weeks | 
| Change in Social Function | The investigators will use the Patient-Reported Outcomes Measurement Information Ability to Participate Social 4a Heal to assess changes in social function. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater inhibition to social participation. | baseline, 3 weeks, 6 weeks | 
| Change in Physical Function | The investigators will use the Patient-Reported Outcomes Measurement Information Ability to Participate Social 6b Heal to assess changes in social function. Every question for this measure has five answer options spanning from 'Without any difficulty' to 'Unable to do'. A higher score indicates greater inhibition in physical function. | baseline, 3 weeks, 6 weeks | 
| Change in Depression | The investigators will use the Patient-Reported Outcomes Measurement Information Depression 4a Heal to assess changes in depression. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater depression symptoms. | baseline, 3 weeks, 6 weeks | 
| Change in Anxiety | The investigators will use the Patient-Reported Outcomes Measurement Information Anxiety 4a Heal to assess changes in anxiety. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater anxiety symptoms. | baseline, 3 weeks, 6 weeks | 
| Illicit Opioid Use | The investigators will use the Patient-Reported Outcomes Measurement Information Opioid Misuse to measure illicit opioid use. Every question for this measure has five answer options spanning from 'Never' to 'Almost Always'. A higher score indicates a greater level of illicit opioid use. | baseline, 3 weeks, 6 weeks |