Twelve-month results for a randomized sham-controlled effectiveness trial of an in-home skills-based virtual reality program for chronic low back pain.

Introduction: Low-risk, accessible, and long-term effective nonpharmacologic behavioral interventions for chronic low back pain (cLBP) are needed. Pain education and cognitive behavioral therapy (CBT) are recommended first-line treatments, but access is poor, treatment effectiveness is variable, and long-term effectiveness is inconsistent. In-home virtual reality (VR)-delivered therapies might address these shortcomings because therapeutic content can be delivered in a consistent and quality-controlled manner. Objective: To determine whether a 56-session, self-administered in-home, Skills-Based VR program for cLBP (RelieVRx) yields long-term reductions in pain intensity and pain interference 12 months posttreatment in a large demographically diverse and clinically severe real-world sample. Methods: Participants were 1,093 demographically diverse individuals with self-reported nonmalignant cLBP >3 months duration and average pain intensity and interference scores >4/10. Participants were randomized to Skills-Based VR or active Sham, and data were collected from January 31, 2022 to October 31, 2023. Pretreatment to 12-month posttreatment analyses were conducted. Results: From baseline to 12 months posttreatment, Skills-Based VR reductions for average pain intensity (1.7 ± 2.1) and pain interference (1.9 ± 2.3) were robust and significantly greater than those found for Sham. More than half of Skills-Based VR participants reported at least a 2-point reduction in pain intensity, pain interference, or both at 12 months posttreatment. Conclusions: A standardized, in-home Skills-Based VR therapy is effective for reducing pain intensity and pain interference, and these effects are maintained to 12 months posttreatment.

Feasibility of In-Home Virtual Reality for Chronic Pain in Sickle Cell Disease.

PURPOSE: This study assessed the feasibility of an in-home virtual reality intervention for chronic pain in adults with sickle cell disease. DESIGN: Two-group, parallel, randomized, multiple methods design with surveys, and interviews. METHODS: Participants were randomized to virtual reality or audio control, with 2-16-minute daily modules for 8 weeks, a daily pain diary survey, and a post study interview. Chronic pain and pain correlates were evaluated at baseline and every 4 weeks for 3 months. Feasibility outcomes were participant enrollment (set at > 50%), questionnaire response (> 50%), intervention use, and cybersickness (< 20%). RESULTS: Of the individuals approached, 67.8% (n = 19) were enrolled. Questionnaire response rates were 100% at baseline, 57.8% at week 4, and < 50% at weeks 8 and 12. The intervention was used for a median of 781 minutes and 210 minutes in the virtual reality and audio groups, respectively. Participants reported slight symptoms of cybersickness with no reports of severe symptoms, and the intervention was acceptable. CONCLUSIONS: Home-based virtual reality can be used in future sickle cell disease research. To further strengthen evaluations of virtual reality in adults with sickle cell who experience chronic pain, future trials should address sample size limitations and incorporate recommended strategies to address cybersickness and questionnaire response. CLINICAL IMPLICATIONS: The first known application of in-home virtual reality for chronic pain in adults with sickle cell disease was successful. Findings can inform future in-home investigations of virtual reality in this underserved population.

Enhancing Home Dialysis Training and Retention through Interactive Virtual Reality.

Patients with end stage kidney disease (ESKD) face challenges in comprehending and pursuing available treatment options, particularly with the rising interest in home-based dialysis. Providers struggle to deliver effective, individualized, and cost-efficient training, leading to lower adoption and retention rates. Cannulation, machine use, and safety training remain significant barriers. Using learning science - the marriage of psychology and the neuroscience of learning - we show that interactive virtual reality (IVR) can address these barriers to home dialysis success by providing the experiential learning necessary for deeper understanding and increased competence. We show that IVR broadly engages multiple learning centers in the brain, thus spreading the wealth of knowledge while reducing cognitive load. We conclude by presenting a practical example of the potential of IVR in objective assessment of home dialysis equipment use and cannulation skills training.

Virtual Reality in Chronic Kidney Disease Education and Training.

Patients with chronic kidney disease (CKD) often struggle to understand their disease and its treatment options. The learning content they receive does not provide the experience necessary to truly understand their disease and its treatment options. Nephrology care providers struggle to convey their knowledge effectively to patients, which leads to dissatisfaction. By applying learning science (the marriage of psychology and the neuroscience of learning), digital technologies like virtual reality can address these shortcomings by providing the experiential learning necessary for a deeper understanding. We show that virtual reality broadly engages multiple learning centers in the brain, thus spreading the wealth of knowledge while reducing cognitive load. We conclude by showing how virtual reality technology could be incorporated into existing CKD education and training workflows.

Correction: Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial.

[This corrects the article DOI: 10.2196/37480.].

Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial.

BACKGROUND: We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). OBJECTIVE: This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. METHODS: E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. RESULTS: Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. CONCLUSIONS: Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.

Using Learning Science to Optimize Chronic Kidney Disease Education for Patients and Providers.

Many patients with chronic kidney disease (CKD) and their providers are dissatisfied with patients' depth of useful knowledge about CKD and its treatment options. This increases stress and decreases satisfaction, while increasing health care costs. In this article, we will apply learning science - the marriage of psychology and the neuroscience of learning - to examine problems seen in current CKD education. The goal is to determine the characteristics of a CKD education curriculum that optimizes the speed of initial learning and long-term retention of CKD and treatment information. We will show that initial learning and long-term retention are optimized when microlearning is incorporated, spaced over time, and supplemented with periodic testing. We conclude by showing how spaced microlearning and testing could be incorporated into a CKD education curriculum.

Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain.

Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to 1 of 2 56-day VR programs: 1) a therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from drm = .56-.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability, and maintained superiority to Sham VR in the 3-month post-treatment period. PERSPECTIVE: We present 3-month follow-up results for 8-week self-administered therapeutic virtual reality (VR) compared to Sham VR in adults with chronic low back pain. Across multiple pain indices, therapeutic VR had clinically meaningful benefits, and superiority over Sham VR. Home-based, behavioral skills VR yielded enduring analgesic benefits; longer follow-up is needed.

A Neuroscientific Framework for Determining the Optimal Kidney Care Education and Training Solution.

Educating and training patients with chronic kidney disease, their caregivers, and health care providers effectively is critical for ensuring high-quality care and achieving successful kidney care outcomes for patients. When this is lacking, it can lead to gaps in care and knowledge that negatively impact patient health and satisfaction, while increasing health care costs. In this article, we offer a three-step framework, grounded in learning science - the marriage of psychology and the neuroscience of learning - to determine the optimal education and training solution for any given learning task. First, one identifies the learning task to be solved. Second, the learning systems in the brain that need to be engaged to learn the specific task must be identified. Finally, the learning solution that optimally engages the relevant brain system is identified. We provide details of each step and examples in which the three-step framework can be applied. In addition, we discuss the use of these learning solutions to educate nephrology care providers about roles they may be considering for their careers, and the knowledge and skills required for those roles.

Understanding implicit and explicit learning in adolescents with and without anorexia nervosa.

BACKGROUND: Cognitive disturbances such as impairments in learning are thought to play a role in adult Anorexia Nervosa (AN). It is remains unclear to what extent these disturbances result from starvation of the brain, or relate to an abnormal premorbid cognitive profile. This study investigates learning processes in adolescents with AN, hypothesizing that implicit learning is intact, as found previously in explicit learning tasks. Secondly, we hypothesized that anxiety and depression symptoms, inherent to AN, are associated to learning processes in AN. METHODS: In total 46 adolescents diagnosed with AN and 44 control participants were administered an implicit category learning task in which they were asked to categorize simple perceptual stimuli (Gabor patches) based on a linear integration (i.e., an implicit task) of orientation and spatial frequency of the stimulus. A subgroup of adolescents (n = 38) also completed a task assessing explicit learning. RESULTS: Model-based analyses indicated that adolescents with AN performed significantly more accurately compared to their healthy peers regardless of whether they used the optimal strategy or not. Depression and anxiety did not relate to learning performance in the AN group. CONCLUSIONS: Overall, our findings of augmented implicit and explicit learning in adolescents with AN corroborate recent studies that suggested higher stimulus-response learning during prediction error paradigms. Learning disturbances in adult AN may then be at least partly due to long-term malnourishment, highlighting the importance of early recognition and refeeding in treatments for AN.

We know that some adults with anorexia nervosa (AN) experience difficulties in learning processes. It is remains unclear to what extent these difficulties result from long-term starvation of the brain. This study looked at learning processes in adolescents with AN who have a relatively short duration of illness. We also investigated whether anxiety and depression affected learning. Forty-six adolescents diagnosed with AN and 44 control participants completed tasks that assessed learning and questionnaires assessing depression and anxiety. We found that adolescents with AN performed more accurately compared to their healthy peers. However, depression and anxiety did not relate to learning performance. Overall, our findings suggest that individuals with AN, relative to their healthy peers, may be quicker in forming automatic responses and behaviors to cues. Learning disturbances in adult AN may then be at least partly due to long-term malnourishment, which highlights the importance of early recognition of AN and refeeding in treatments for AN.

Correction: Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/25291.].

Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE: In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS: We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. RESULTS: The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS: Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/25291.

An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19.

BACKGROUND: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. CONCLUSIONS: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.

COVID-19 and mental health: A review and the role of telehealth and virtual reality.

On March 12, 2020, with more than 20,000 confirmed cases and almost 1000 deaths in the European Region, the World Health Organization classified the COVID-19 outbreak as a pandemic. As of August 15, 2020, there are 21.5 million confirmed cases of COVID-19 and over 766,000 deaths from the virus, worldwide. Most governments have imposed quarantine measures of varied degrees of strictness on their populations in attempts to stall the spread of the infection in their communities. However, the isolation may have inflicted long-term psychological injury to the general population and, in particular, to at-risk groups such as the elderly, the mentally ill, children, and frontline healthcare staff. In this article, we offer the most up-to-date review of the effects of COVID-19 confinement on all the disorders listed in the Diagnostic and Statistical Manual of Mental Disorders. We make data-driven predictions of the impact of COVID-19 confinement on mental health outcomes and discuss the potential role of telemedicine and virtual reality in mental health screening, diagnosis, treatment, and monitoring, thus improving the above outcomes in such a difficult time.