Probing white matter microstructure in youth with chronic pain and its relation to catastrophizing using neurite orientation dispersion and density imaging.

ABSTRACT: Chronic pain is common in young people and can have a major life impact. Despite the burden of chronic pain, mechanisms underlying chronic pain development and persistence are still poorly understood. Specifically, white matter (WM) connectivity has remained largely unexplored in pediatric chronic pain. Using diffusion-weighted imaging, this study examined WM microstructure in adolescents (age M = 15.8 years, SD = 2.8 years) with chronic pain (n = 44) compared with healthy controls (n = 24). Neurite orientation dispersion and density imaging modeling was applied, and voxel-based whole-white-matter analyses were used to obtain an overview of potential alterations in youth with chronic pain and tract-specific profile analyses to evaluate microstructural profiles of tracts of interest more closely. Our main findings are that (1) youth with chronic pain showed widespread elevated orientation dispersion compared with controls in several tracts, indicative of less coherence; (2) signs of neurite density tract-profile alterations were observed in several tracts of interest, with mainly higher density levels in patients; and (3) several WM microstructural alterations were associated with pain catastrophizing in the patient group. Implicated tracts include both those connecting cortical and limbic structures (uncinate fasciculus, cingulum, anterior thalamic radiation), which were associated with pain catastrophizing, as well as sensorimotor tracts (corticospinal tract). By identifying alterations in the biologically informative WM microstructural metrics orientation dispersion and neurite density, our findings provide important and novel mechanistic insights for understanding the pathophysiology underlying chronic pain. Taken together, the data support alterations in fiber organization as a meaningful characteristic, contributing process to the chronic pain state.

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain.

ABSTRACT: Graded exposure treatment (GET) is a theory-driven pain treatment that aims to improve functioning by exposing patients to activities previously feared and avoided. Combining key elements of GET with acceptance-based exposure, GET Living (GL) was developed for adolescents with chronic pain (GL). Based on robust treatment effects observed in our single-case experimental design pilot trial of GL (NCT01974791), we conducted a 2-arm randomized clinical trial comparing GL with multidisciplinary pain management (MPM) comprised of cognitive behavioral therapy and physical therapy for pain management (NCT03699007). A cohort of 68 youth with chronic musculoskeletal pain (M age 14.2 years; 81% female) were randomized to GL or MPM. Owing to COVID-19 restrictions, 54% of participants received zoom video delivered care. Assessments were collected at baseline, discharge, as well as at 3-month and 6-month follow-up. Primary outcomes were self-reported pain-related fear and avoidance. Secondary outcomes were child functional disability and parent protective responses to child pain. As hypothesized, GL improved in primary and secondary outcomes at 3-month follow-up. Contrary to our superiority hypothesis, there was no significant difference between GL and MPM. Patients reported both GL and MPM (in person and video) as credible and were highly satisfied with the treatment experience. Next steps will involve examining the single-case experimental design data embedded in this trial to facilitate an understanding of individual differences in treatment responses (eg, when effects occurred, what processes changed during treatment within the treatment arm). The current findings support GET Living and MPM for youth with chronic pain.

Body Mindsets are Associated With Pain and Threat-Related Risk Factors for Pain in Survivors of Childhood Cancer.

Pain is a common consequence of childhood cancer. While most research has examined biomedical predictors of post-cancer pain, biopsychosocial conceptualisations such as the cancer threat interpretation (CTI) model hold promise for guiding comprehensive pain management strategies. Guided by the CTI model, this cross-sectional study evaluated correlates of post-cancer pain in childhood cancer survivors including threat-related risk factors (bodily threat monitoring, fear of cancer recurrence, help-seeking) and mindsets about the body. In the preceding three months, 21.8% of the survivors reported chronic pain (>3 months), and 14.3% experienced pain most days. Greater bodily threat monitoring, more fear of cancer recurrence, and more help-seeking were associated with more pain. There was heterogeneity in the mindsets that survivors of childhood cancer hold about their bodies. Holding the mindset that the 'body is an adversary' was associated with more pain, greater bodily threat monitoring, and more fear of cancer recurrence. Holding the mindset that the 'body is responsive' was associated with less bodily threat monitoring, while the mindset that the 'body is capable' was associated with greater help-seeking. A path model demonstrated a significant combined indirect effect of the 'body is an adversary' mindset on pain through bodily threat monitoring and fear of cancer recurrence. Overall, this study supported that a sub-group of childhood cancer survivors experience persistent and interfering pain and provided cross-sectional support for threat-related correlates for pain aligning with the CTI model. Body mindsets were associated with pain and threat-related correlates and may represent a novel target to support survivors with pain. PERSPECTIVE: This article presents associations of body mindsets, threat-related risk factors, and pain in survivors of childhood cancer (aged 11-25), guided by the Cancer Threat Interpretation model. The study indicates that body mindsets may be novel targets to embed in comprehensive post-cancer pain management approaches to support young survivors with pain.

Application of PainDETECT in pediatric chronic pain: how well does it identify neuropathic pain and its characteristics?

Introduction: Neuropathic pain (NP) arises from nerve damage or disease, and when not defined, it can impair function and quality of life. Early detection allows for interventions that can enhance outcomes. Diagnosis of NP can be difficult if not properly evaluated. PainDETECT is a NP screening tool developed and successfully used in adults. Objectives: We evaluated the validity of painDETECT in a pediatric population. Methods: Adolescents and young adults (10-19 years old) completed painDETECT and quantitative sensory testing (QST), which assessed mechanical allodynia and hyperalgesia, common symptoms of NP. Pain diagnoses, including neuropathic pain (n = 10), were collected through documentation in the medical chart. Descriptive statistics were used to examine age, gender, pain diagnoses, and painDETECT scores. Kruskal-Wallis H tests were conducted to examine differences in QST results across painDETECT categorizations. Results: Youth with chronic pain (N = 110, Mage = 15.08 ± 2.4 years, Nfemale = 88) and peers without pain (N = 55, Mage = 15.84 ± 3.9 years, Nfemale = 39) completed the painDETECT. The painDETECT scores for youth with pain (M = 12.7 ± 6.76) were significantly higher than those for peers without pain (M = 2.05 ± 2.41). PainDETECT demonstrated 80% sensitivity and 33% specificity in a pediatric population. Individuals who screened positively on the PainDETECT had significantly higher mechanical allodynia (M = 0.640 ± 0.994) compared with those who screened negatively (M = 0.186 ± 0.499; P = 0.016). Conclusion: PainDETECT demonstrated the ability to screen for NP, and QST mechanical allodynia results were consistent with a positive NP screen. Results of the study offer preliminary support for the ongoing assessment of the painDETECT as a brief, inexpensive, and simple-to-use screening tool for pediatric patients with primary pain complaints.

The bodily threat monitoring scale: Development and preliminary validation in adult and childhood cancer survivors.

OBJECTIVE: Bodily threat monitoring is a core clinical feature of Fear of cancer recurrence (FCR) and is targeted in psycho-oncology treatments, yet no comprehensive self-report measure exists. The aim of this study was the theory-informed development and initial validation of the Bodily Threat Monitoring Scale (BTMS). METHODS: Adult survivors of breast and gynaecological cancers (Study 1: N = 306, age = 37-81 years) and childhood cancer survivors (Study 2: N = 126, age = 10-25 years) completed the BTMS, designed to assess how individuals monitor for and interpret uncertain symptoms as indicating that something is wrong with their body. Participants completed measures to assess construct and criterion validity of the BTMS, and childhood cancer survivors (Study 2) completed the BTMS again 2 weeks later to assess test-retest reliability. RESULTS: The 19-item BTMS demonstrated excellent internal consistency across adult and childhood cancer samples (α = 0.90-0.96). Factor analyses indicated two subscales capturing 1. Monitoring of bodily sensations and 2. Threatening interpretations of bodily sensations. Two-week stability estimates were acceptable. For construct validity, the BTMS correlated with body vigilance and anxiety sensitivity. The BTMS also demonstrated criterion validity, yielding significant associations with FCR, intolerance of uncertainty, help-seeking behaviours, and quality of life. The BTMS was associated with FCR while controlling for body vigilance and anxiety sensitivity, indicating a unique contribution of this theory-informed measure. CONCLUSIONS: The BTMS shows evidence of sound psychometric properties and could be used to elucidate the role of bodily threat monitoring in the maintenance and management of FCR.

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults.

Chronic pain is prevalent across the life span and associated with significant individual and societal costs. Behavioral interventions are recommended as the gold-standard, evidence-based interventions for chronic pain, but barriers, such as lack of pain-trained clinicians, poor insurance coverage, and high treatment burden, limit patients' ability to access evidenced-based pain education and treatment resources. Recent advances in technology offer new opportunities to leverage innovative digital formats to overcome these barriers and dramatically increase access to high-quality, evidenced-based pain treatments for youth and adults. This scoping review highlights new advances. First, we describe system-level barriers to the broad dissemination of behavioral pain treatment. Next, we review several promising new pediatric and adult pain education and treatment technology innovations to improve access and scalability of evidence-based behavioral pain treatments. Current challenges and future research and clinical recommendations are offered.

Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach.

BACKGROUND: Increasing the access to and improving the impact of pain treatments is of utmost importance, especially among youths with chronic pain. The engagement of patients as research partners (in contrast to research participants) provides valuable expertise to collaboratively improve treatment delivery. OBJECTIVE: This study looked at a multidisciplinary exposure treatment for youths with chronic pain through the lens of patients and caregivers with the aim to explore and validate treatment change processes, prioritize and develop ideas for improvement, and identify particularly helpful treatment elements. METHODS: Qualitative exit interviews were conducted with patients and caregivers at their discharge from 2 clinical trials (ClinicalTrials.gov NCT01974791 and NCT03699007). Six independent co-design meetings were held with patients and caregivers as research partners to establish a consensus within and between groups. The results were validated in a wrap-up meeting. RESULTS: Patients and caregivers described that exposure treatment helped them better process pain-related emotions, feel empowered, and improve their relationship with each other. The research partners developed and agreed upon 12 ideas for improvement. Major recommendations include that pain exposure treatment should be disseminated more not only among patients and caregivers but also among primary care providers and the general public to facilitate an early referral for treatment. Exposure treatment should allow flexibility in terms of duration, frequency, and delivery mode. The research partners prioritized 13 helpful treatment elements. Most of the research partners agreed that future exposure treatments should continue to empower patients to choose meaningful exposure activities, break long-term goals into smaller steps, and discuss realistic expectations at discharge. CONCLUSIONS: The results of this study have the potential to contribute to the refinement of pain treatments more broadly. At their core, they suggest that pain treatments should be disseminated more, flexible, and transparent.

"You don't accept he's completely ok": a reflexive thematic analysis of parents' roles in monitoring their child's health and symptoms after finishing childhood cancer treatment.

OBJECTIVES/PURPOSE: Childhood cancer survival brings continued mental and physical health challenges both for the child and for the family. In this study, we investigated how parents viewed their roles in their child's health and symptom monitoring during the survivorship period. METHODS: Twenty-one parents of childhood cancer survivors (n = 18 mothers; parent mage = 49.78 years, child mage = 18.50 years; range = 12-25 years), whose children were at least one year off-treatment (m = 3.67 years; SD = 2.25; various diagnoses), completed semi-structured interviews. Interviews were recorded, transcribed, and analyzed using reflexive thematic analysis. RESULTS: Analyses generated three themes which reflect roles that parents may adopt in the context of monitoring symptoms in their childhood cancer survivor. "Vigilant Mama and Papa" (theme 1) described parents who expressed a strong sense of responsibility for protecting their child's health during survivorship resulting in careful monitoring of their child's symptoms and health. "Pragmatic Mamas and Papas" (theme 2) described parents who adopted an approach to symptom and health monitoring that emphasized moving past cancer and focusing on the future. Finally, "Encouraging Mamas and Papas" (theme 3) described parents who focused on educating and preparing their child to develop an autonomous approach to health and symptom self-monitoring as they transitioned to survivorship and adulthood. CONCLUSION: Parents take on varying roles in monitoring their child's symptoms and health after finishing childhood cancer treatment. IMPLICATIONS FOR CANCER SURVIVORS: Understanding the ways in which parents continue to be involved in their child's cancer journey helps researchers develop interventions to support dyadic coping in survivorship.

International Survey of Pediatric Oncologists' Beliefs and Communication Practices Regarding Symptom Self-Monitoring by Childhood Cancer Survivors.

PURPOSE: Childhood cancer survivors report self-monitoring for and worrying about symptoms of disease recurrence and secondary cancers, although symptom-related worry is associated with poorer health-related quality of life. This survey captured pediatric oncologists' beliefs and communication practices regarding symptom self-monitoring for childhood cancer survivors. METHODS: Using a closed-loop snowball sampling technique, pediatric oncologists completed an online survey regarding the importance of symptom self-monitoring for off-therapy patients, the degree to which symptom self-monitoring was perceived to cause stress and worry, and communication practices. RESULTS: 196 pediatric oncologists (White [78%]; female [64%]; Mage = 47 years) from every continent except Antarctica participated. Oncologists believed it is important for off-therapy patients to self-monitor for symptoms of cancer recurrence (90%) and treatment late effects (94%), although some noted that recurrence (30%) and late effects (55%) are typically detected by routine surveillance before symptoms appear. Oncologists varied in their beliefs that off-therapy patients do (31%) or do not (31%) worry unnecessarily about symptoms of recurrence. Two thirds (62%) of oncologists reported often/always discussing with off-therapy patients which symptoms could indicate cancer recurrence, whereas fewer than half (43%) often/always discussed which symptoms were unlikely to indicate recurrence. Oncologists identified a need for education regarding how to communicate around symptom self-monitoring and the potential utility of a screening tool to identify those who worry excessively. CONCLUSION: Despite nearly universal belief that their off-therapy patients should self-monitor for symptoms of disease recurrence and late effects, a substantial proportion of pediatric oncologists do not counsel patients on symptom self-monitoring. Since nearly one-third believe that off-therapy patients worry unnecessarily about symptoms of recurrence, improving patient education regarding which symptoms are and are not medically concerning could decrease stress and improve health-related quality of life for pediatric cancer survivors.

Targeting Pain Science Education in Youth With Chronic Pain: What Are the Sticking Points for Youth and Their Parents?

OBJECTIVES: An important part of providing pain science education is to first assess baseline knowledge and beliefs about pain, thereby identifying misconceptions and establishing individually-tailored learning objectives. The Concept of Pain Inventory (COPI) was developed to support this need. This study aimed to characterize the concept of pain in care-seeking youth and their parents, to examine its clinical and demographic correlates, and to identify conceptual gaps. MATERIALS AND METHODS: Following an initial interdisciplinary evaluation, a cohort of 127 youth aged 8 to 18 years, and their parents, completed a series of questionnaires. RESULTS: Parents had slightly higher COPI scores than youth did, reflecting parents' greater alignment with contemporary pain science. The moderate positive association with older age among youth ( r =.32) suggests that COPI is sensitive to cognitive development and life experiences. Youth and parent COPI responses were weakly associated ( r =0.24), highlighting the importance of targeting the concept of pain in both groups. For both parents and youth, 'Learning about pain can help you feel less pain' was the least endorsed concept. This conceptual 'gap' is a key point of intervention that could potentially lead to greater engagement with multidisciplinary pain treatment. DISCUSSION: The COPI appears useful for identifying conceptual gaps or 'sticking points'; this may be an important step to pre-emptively address misconceptions about pain through pain science education. Future research should determine the utility of COPI in assessing and treating youth seeking care for pain. The COPI may be a useful tool for tailoring pain science education to youth and their parents.

Virtual Reality-Augmented Physiotherapy for Chronic Pain in Youth: Protocol for a Randomized Controlled Trial Enhanced With a Single-Case Experimental Design.

BACKGROUND: Chronic musculoskeletal (MSK) pain is a prominent health concern, resulting in pain-related disability, loss of functioning, and high health care costs. Physiotherapy rehabilitation is a gold-standard treatment for improving functioning in youth with chronic MSK pain. However, increasing physical activity can feel unattainable for many adolescents because of pain-related fear and movement avoidance. Virtual reality (VR) offers an immersive experience that can interrupt the fear-avoidance cycle and improve engagement in physiotherapy. Despite promising initial findings, data are limited and often lack the rigor required to establish VR as an evidence-based treatment for MSK pain. OBJECTIVE: This trial evaluates physiorehabilitation with VR in adolescents with MSK pain. This protocol outlines the rationale, design, and implementation of a randomized controlled trial enhanced with a single-case experimental design. METHODS: This study is a 2-group randomized controlled trial assessing the use of physiorehabilitation with VR in adolescents with MSK pain. The authors will collaborate with physical therapists to integrate VR into their standard clinical care. For participants enrolled in standard physiotherapy, there will be no VR integrated into their physical therapy program. Primary outcomes include physical function and engagement in VR. Secondary outcomes include pain-related fear and treatment adherence. Moreover, we will obtain clinician perspectives regarding the feasibility of integrating the intervention into the flow of clinical practice. RESULTS: The pilot study implementing physiorehabilitation with VR demonstrated that high engagement and use of physiorehabilitation with VR were associated with improvements in pain, fear, avoidance, and function. Coupled with qualitative feedback from patients, families, and clinicians, the pilot study results provide support for this trial to evaluate physiorehabilitation with VR for youth with chronic MSK pain. Analysis of results from the main clinical trial will begin as recruitment progresses, and results are expected in early 2024. CONCLUSIONS: Significant breakthroughs for treating MSK pain require mechanistically informed innovative approaches. Physiorehabilitation with VR provides exposure to progressive challenges, real-time feedback, and reinforcement for movement and can include activities that are difficult to achieve in the real world. It has the added benefit of sustaining patient motivation and adherence while enabling clinicians to use objective benchmarks to influence progression. These findings will inform the decision of whether to proceed with a hybrid effectiveness-dissemination trial of physiorehabilitation with VR, serving as the basis for potential large-scale implementation of physiorehabilitation with VR. TRIAL REGISTRATION: ClinicalTrials.gov NCT04636177; https://clinicaltrials.gov/ct2/show/NCT04636177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40705.

Altered anterior insula functional connectivity in adolescent and young women with endometriosis-associated pain: Pilot resting-state fMRI study.

BACKGROUND: Endometriosis is the leading cause of chronic pelvic pain. Alterations in brain functional connectivity have been reported in adult women with endometriosis-associated pain (EAP), however, it is still unknown if similar patterns of changes exist in adolescents. METHODS: In this pilot study, resting-state fMRI scans were obtained from 11 adolescent and young women with EAP and 14 healthy female controls. Using a seed-to-voxel approach, we investigated functional connectivity between the anterior insula, medial prefrontal cortex, and the rest of the brain. Furthermore, we explored whether potential functional connectivity differences were correlated with clinical characteristics including disease duration, pain intensity, and different psychosocial factors (pain catastrophizing, fear of pain, functional disability, anxiety, and depression). RESULTS: Our findings revealed that patients with EAP demonstrated significantly decreased connectivity between the right anterior insula and two clusters: one in the right cerebellum, and one in the left middle frontal gyrus compared to controls. Additionally, functional connectivity between the right anterior insula and the right cerebellum was positively associated with pain intensity levels. In patients with EAP, brain changes were also correlated with state anxiety and fear of pain. CONCLUSIONS: Our results are relevant not only for understanding the brain characteristics underlying EAP at a younger age, but also in enhancing future pain treatment efforts by supporting the involvement of the central nervous system in endometriosis.

Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy.

INTRODUCTION: Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-related fear and avoidance of activities being identified as substantial barriers to treatment engagement. Evidence supports targeted psychological and physical interventions to address these barriers (eg, graded-exposure treatment), but accessibility to intervention is undermined by a shortage of services outside of urban areas, high treatment-related costs, and long provider waitlists; highlighting the need to develop digitally delivered behavioural intervention, using agile and iterative study designs that support rapid development and timely dissemination. METHODS AND ANALYSIS: This study seeks to develop an effective and scalable intervention for youth with chronic pain and their caregivers. This paper presents a user-centred protocol for the development and refinement of a digital exposure treatment for youth and caregivers, as well as the study design to examine feasibility and preliminary efficacy of the treatment using single-case experimental design (SCED). Assessments include daily diaries, completed from baseline and daily throughout the intervention (~6 weeks), and at 3-month follow-up, as well as self-report measures completed at baseline, end of intervention and 3-month follow-up. Primary outcomes include treatment satisfaction, treatment expectancy, adherence to daily dairies and functional disability. Secondary outcomes are pain-related fear and avoidance of activities, pain catastrophising and pain acceptance. We will present descriptive and model-based inference analyses, based on SCED reporting guidelines. We will calculate effect sizes for each individual on each outcome. We will examine mean treatment expectancy, credibility and satisfaction scores, and patient drop-out percentage. ETHICS AND DISSEMINATION: This study is approved by the Institutional Review Board at Stanford University (protocol #53323). Findings will be actively disseminated through peer-reviewed journals, conference presentations and social media. TRIAL REGISTRATION NUMBER: NCT05079984.

Microtemporal Relationships in the Fear Avoidance Model: An Ecological Momentary Assessment Study.

OBJECTIVES: Current literature in pediatric pain evaluates the Fear Avoidance model (FAM) pathways at the trait (or macrotemporal) level, but it is unknown if these pathways also occur at the state (or microtemporal) level. Identifying microtemporal processes can improve our understanding of how the relationships within the Fear Avoidance constructs vary when specific Fear Avoidance variables wax and wane. We hypothesized that changes in FAM constructs would be associated with changes in the next variable in the sequence on a microtemporal level, including: (1) higher pain when there is more pain-related fear, (2) higher pain-related fear when there is more avoidance, and (3) higher avoidance when there is more reported disability. METHODS: 71 pediatric patients with chronic abdominal pain ( M =13.34 y, SD=2.67 y) reported pain severity, pain-related fear, and avoidance via ecological momentary assessments over 14 days. RESULTS: Our results indicated significant microtemporal relationships between Fear Avoidance constructs for pain predicting pain-related fear, pain-related fear predicting avoidance, and avoidance predicting disability. DISCUSSION: The current study suggests that the ways in which the FAM is related to various aspects of pain functioning differs on a state-level, which adds new clinical and research opportunities.

Integrated Features for Optimizing Machine Learning Classifiers of Pediatric and Young Adults With a Post-Traumatic Headache From Healthy Controls.

Post-traumatic headache (PTH) is a challenging clinical condition to identify and treat as it integrates multiple subjectively defined symptoms with underlying physiological processes. The precise mechanisms underlying PTH are unclear, and it remains to be understood how to integrate the patient experience with underlying biology when attempting to classify persons with PTH, particularly in the pediatric setting where patient self-report may be highly variable. The objective of this investigation was to evaluate the use of different machine learning (ML) classifiers to differentiate pediatric and young adult subjects with PTH from healthy controls using behavioral data from self-report questionnaires that reflect concussion symptoms, mental health, pain experience of the participants, and structural brain imaging from cortical and sub-cortical locations. Behavioral data, alongside brain imaging, survived data reduction methods and both contributed toward final models. Behavioral data that contributed towards the final model included both the child and parent perspective of the pain-experience. Brain imaging features produced two unique clusters that reflect regions that were previously found in mild traumatic brain injury (mTBI) and PTH. Affinity-based propagation analysis demonstrated that behavioral data remained independent relative to neuroimaging data that suggest there is a role for both behavioral and brain imaging data when attempting to classify children with PTH.

Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials.

OBJECTIVES: COVID-19 abruptly halted in-person clinical care and research requiring a shift to virtual assessment and treatment. This unexpected transition of a 2-arm randomized controlled trial (RCT) examining interdisciplinary graded exposure treatment (GET Living) compared with multidisciplinary pain management for youth with chronic pain provided an opportunity to implement the first remotely delivered exposure treatment and remotely delivered biomechanical assessment for pediatric chronic pain. Here we describe these new approaches and provide lessons learned to inform future efforts in digital health care. METHODS: A total of 68 youth (M=14.2 y; 80.9% female) were enrolled in the RCT (n=31 in-person, n=5 hybrid, n=32 virtual, n=9 withdrew). Of those withdrawn, n=3 withdrew due to COVID-19 related reasons. Some RCT elements required slight modification (eg, e-consent, actigraphy deployment, recruitment, and screening), while others were significantly altered (eg, session format and lab-based biomechanical assessment). Data from exit interviews were also examined to assess perspectives on the virtual format transition. RESULTS: Results showed an increased enrollment rate when virtual care was an option (70.7%) compared with in-person (44.3%). Equivalent rates of completion for daily assessment (in-person, 72.8%; virtual, 73.3) were also observed, and participants described enhanced experience when able to complete exercises and exposures in their home environment during session (vs. a rehabilitation gym) allowing for genuine in vivo exposures (eg, household chores, riding bicycles). DISCUSSION: Overall, our data demonstrate acceptability, feasibility, and equivalent patient engagement to virtual treatment. Novel methods implemented in this RCT can inform trial design and measures of clinical endpoints for future digital health interventions.