Beth Darnall - US grants

? DESCRIPTION (provided by applicant): Chronic low back pain (CLBP) is the most common chronic pain condition and is the second leading cause of disability in the U.S. Pain catastrophizing (PC)--a pattern of negative cognitive-emotional responses to actual or anticipated pain-is significantly associated with the development and maintenance of CLBP as well as disability. PC undermines CLBP treatments, thus contributing to a cycle of treatment futility and wasted expenditure. While Cognitive Behavioral Therapy (pain-CBT) treats PC, group treatment involves 6-10 sessions and thus poses substantial burdens of time, travel, and cost. Therefore, there is a critical need to develop and disseminate efficient, low-cost treatments that specifically reduce PC. Accordingly, we developed a single-session, 2-hour pain-CBT class that solely treats PC (From Catastrophizing to Recovery; FCR). Our pilot data revealed large effect sizes for FCR in a chronic pain sample and superior outcomes for medical and psychological across PROMIS domains, as compared to a 'treatment as usual' matched clinic cohort. We propose to conduct a 3-arm comparative efficacy RCT in 231 patients with CLBP comparing: (A) FCR, (B) a health education control, and (C) an 8-session pain-CBT class. Our primary endpoint is PC 3 months post- treatment and our secondary endpoint is PC 6 months post-treatment. We hypothesize that FCR will be superior to active control and non-inferior to the 8-session pain-CBT class for improving PC and pain-related outcomes measured by our PROMIS platform. An innovative aspect of the application is our proposal to develop and validate a brief version Daily PCS measure, and apply the measure with high frequency sampling methods to elucidate the mechanics of PC, and to characterize how positive response to active intervention reduces the influence of PC episodes. Additional novel methods our specialized PROMIS platform; actigraphy for objective sleep and activity measurement; and a customized 'FCR Relaxation Resource' app (on Nexus 7 tablets) to objectively quantify skills use in the FCR group. Our rich dataset will allow for detailed phenotyping of responders / non-responders for both active treatments using machine learning and other advanced analytics. We will use daily ratings across a longitudinal timeframe to characterize how PC changes in response to treatment, as well as the mechanistic influence of PC on pain, sleep, activity, and other variables. Our proposal addresses the NCCAM priorities to (1) alleviate chronic pain, (2) study our mind-body intervention in a real-world setting, and (3) advance scientific understanding of the mechanisms of PC.

Project Summary: The primary goals of this K24 application are to allow Beth Darnall, PhD to (1) provide high- quality and intensive mentorship of early-career investigators in patient-oriented research (POR); and (2) acquire new training in research methodologies to support expansion of digital health research in populations on the continuum of opioid use disorder. A K24 award will provide Dr. Darnall with the critical protected time for POR and mentoring that would otherwise be spent on administrative and clinical responsibilities. Dr. Darnall is Associate Professor and Director of the Stanford Pain Relief Innovations Lab at the Stanford University School of Medicine. Dr. Darnall proposes to extend her line of research on scalable digital behavioral medicine to people with comorbid chronic pain and prescription opioid misuse, and then conduct a national virtual randomized controlled trail to investigate impacts on pain and opioid outcomes. Her mentoring plan includes structured mentoring in: (1) designing and implementing POR studies; (2) preparing scientific papers and presentations; (3) writing and submitting successful research grant applications; (4) ethical and responsible conduct of research; and (5) professionalism and successful navigation of the academic process to achieve scientific independence. Trainees will be derived from multiple current sources including the Stanford Clinical and Translational Science Award (CTSA), the Pain Division's NIDA T32 program on pain and substance use disorder, the Pain Division's pain psychology and board certified pain physician fellowship programs, the Stanford fellowship for the Vice Provost for Undergraduate Education (VPUE), and her multiple active national and international research collaborations. Dr. Darnall will accomplish her mentoring plan through a combination of individual and group meetings, collaborative mentoring, role modeling, and participation in interdepartmental lectures and at national meetings. Additionally, she will closely integrate her mentees into the Stanford CTSA mentoring program and the extensive offerings of the Stanford Office for Faculty Diversity and Development, including the NIH K-series and R-series grant intensive writing programs. Her career development plan includes training in digital health design to optimize digital behavioral treatments for enhanced user engagement and response, as well as trainings in implementation science, opioid policy, and advanced mentoring from the Stanford Faculty Leadership Program. Dr. Darnall has outstanding resources, long- standing successful research collaborations, and a substantial active funding portfolio. The proposed K24 research and other planned projects are expected to lead to new directions and innovations in research on pain and the continuum of opioid use disorder, and significantly contribute to our scientific understanding of these disabling conditions. Dr. Darnall will leverage the K24 and her existing resources to provide crucial training to the next generation of scientists dedicated to conducting impactful patient-oriented research.