VR group participants were mailed an Oculus Go Virtual Reality headset preloaded with VR software developed by AppliedVR. Treatment content consisted of a variety of 21 sessions to support participants in learning cognitive and behavioral self-management skills based on evidence-based CBT principles and skills, biofeedback and mindfulness strategies used in pain management. The program was designed to improve self-regulation of cognitive, emotion, and physiological response to stress and pain.

The audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the Audio program included didactic and experiential content that was not identifical but was closely matched to the VR content (sans references to visual imagery that would be confusing in the absence of visual content). Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day.

Chronic Pain

Didactic content delivered in virtual reality to support participants in learning cognitive and behavioral self-management skills based on cognitive-based therapy, biofeedback, and mindfulness strategies for pain management.

PainCare VR

The audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the VR program could not be included in the audio. Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day.

Audio content

US Department of Health and Human Services Pain Management Best Practices Interagency Task Force Report

AppliedVR, Inc.

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study

VR use will be calculated as the total number of sessions launched for the VR group.

Participant satisfaction ratings will be assessed using the question, "How satisfied or dissatisfied are you with the ability of this VR (Audio) program to relieve your symptoms" on a 5-point scale (1=Extremely Dissatisfied to 5=Extremely Satisfied). Satisfaction with treatment will be reported as percentages for the satisfaction categories 1-5 (on day 22).

Nausea and motion sickness will be assessed on day 22 (post-treatment survey) using the question, "Did you experience any motion sickness or nausea while using VR?" on 4-point with 0=Never, 1=Sometimes, 2=Often, and 3=Always. The proportion of participants who did not experience any nausea/motion sickness will be reported.

Compare between group (VR vs Audio) pre-post treatment pain intensity (0-10 numeric rating scale) end of treatment on Day 21.

Department of Defense/Veterans Administration (DoD/VA) Scale assesses pain interference over the previous 24 hours at two time points: Baseline and end of treatment on Day 21 (0=does not interfere; 10=completely interferes). Between group (VR vs Audio) pre-post treatment for pain interference will be compared.

Department of Defense/Veterans Administration (DoD/VA) Scale assesses activity interference over the previous 24 hours at two time points: Baseline and end of treatment on Day 21 (0=does not interfere; 10=completely interferes). Between group (VR vs Audio) pre-post treatment for activity interference will be compared.

Department of Defense/Veterans Administration (DoD/VA) Scale assesses mood interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21(0=does not interfere; 10=completely interferes). The investigators will compare mood interference between group (VR vs Audio) pre-post treatment.

Department of Defense/Veterans Administration (DoD/VA) Scale assesses sleep interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21 (0=does not interfere; 10=completely interferes). The investigators will compare sleep interference between group (VR vs Audio) pre-post treatment.

Department of Defense/Veterans Administration (DoD/VA) Scale assesses stress interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21 (0=does not interfere; 10=completely interferes). The investigators will compare stress interference between group (VR vs Audio) pre-post treatment .

Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 0-4 scale (0=not at all; 4=all the time). The PCS is assessed at baseline and post-treatment at day 22. There is no specific time referent for this measure. The investigators compared PCS between group (VR vs Audio) pre-post treatment.

The 2-item PSEQ (PSEQ-2) is used to assess pain self-efficacy. Respondents rate their responses to the items using a 7-point scale ranging from 0 (Not at all confident) to 4 (Completely confident). The two item scores are summed to create a total score. The investigators will compare pain self-efficacy (PSEQ-2) between group (VR vs Audio) pre-post treatment .

AppliedVR Inc.

Parallel group design where enrolled participants are randomly assigned to one of two treatment groups: Virtual reality behavioral medicine for chronic pain or Audio behavioral medicine for chronic pain

Participants will receive lactose placebo tablets, encapsulated in opaque capsules, and will be asked to take one capsule daily for seven days at night-time, by mouth

Participants will receive 20mg atorvastatin tablets, encapsulated in opaque capsules, and will be asked to take one capsule daily for seven days at night-time, by mouth

Healthy

Atorvastatin 20mg

Lactose placebo

Riccardo De Giorgi

7-day Atorvastatin and Emotional Processing

The Effect of Seven-Day Atorvastatin Administration on Emotional Processing, Reward Processing, and Inflammation in Healthy Volunteers

Faces representing varying degrees [from "neutral" (0%) to "full prototypical emotion" (100%) of basic emotions (happiness, fear, anger, disgust, sadness, surprise)] are displayed on the screen and participants are asked to quickly and correctly classify them. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

Faces acting as positive or negative emotional stimuli (happy or fearful facial expressions) are presented together with a matched neutral face. One is presented above and one below a central fixation point. Subsequently, a probe appears behind one of the two faces and participants are asked to quickly indicate the position of the probe. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

Words describing positive and negative personality characteristics are presented, and participants are asked to quickly indicate whether they would like or dislike being described with the presented word. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

After a delay from the Emotional categorisation task, participants are asked to recall and write down as many words as possible from it. Accuracy in recall of positive vs negative stimuli are compared between those receiving drug and placebo.

The original personality descriptors in the Emotional categorisation task, plus an equal number of matched distractor words, are presented, and participants are asked to indicate whether they recognise it from the Emotional categorisation task. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

During a computer-based task, participants are instructed to learn and select which images are associated with wins rather than losses. Accuracy and reaction times are assessed and compared between those receiving drug and placebo.

Changes in high sensitivity-C Reactive Protein (hs-CRP) from baseline to seven-day, comparing those receiving drug and placebo

To comply with the General Data Protection Regulation (GDPR) and the new Data Protection Act, personal data will be deleted as soon as possible after it is no longer needed for the study.
Screening information: For volunteers who do not wish to be contacted for future studies, screening information (including contact details) will be stored for up to one year of completing study analyses, and then destroyed by shredding. Contact details may be retained after the end of the study for participants who have agreed to be contacted for future studies.
Consent forms: Consent forms will be kept for 10 years after the end of the study, and then destroyed by shredding.

University of Oxford

Wellcome Trust

Participants will be randomised, in a double-blind fashion, to either placebo or atorvastatin. The randomisation code will be drawn up by a researcher not involved in the study using an online randomisation tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists).

The atorvastatin drug and the placebo will be encapsulated in identical capsules. Participants will not be aware of the treatment that they will be receiving; neither will the researcher. Allocation of treatments will be recorded on a Randomisation List, which will be updated when each new participant enters the randomised phase. The list will be held by a scientist uninvolved in the study.

Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.

Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.

Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).

Mindfulness Training for Smokers

Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).

Interactive Learning for Smokers

Total

Sex: Female, Male

Region of Enrollment

Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day

Smoking Abstinence

Timeline follow back participant self-report of daily alcohol use.

Alcohol Use in Study Subjects vs Controls

Overall Study

James M. Davis MD, Assistant Professor, Duke University

Nicotine Dependence

Alcohol Use

The provides the Mindfulness Training for Smokers intervention (7 weeks long).

This provides the Interactive Learning for Smokers intervention (7 weeks long).

University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention

Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

University of Wisconsin, Madison

National Institute on Drug Abuse (NIDA)

Schizophrenia

Shiatsu treatment provided in 40-minute sessions, twice a week for 4 weeks

anhedonia/nausea

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain

7-day Atorvastatin and Emotional Processing

Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

Shiatsu Adjuvant Therapy For Schizophrenia

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