Initial Evidence for a Brief Psychological Telehealth Intervention for Patients with Chronic Masticatory Muscle Pain

Abstract Chronic masticatory muscle pain disorders (MMPD) affect between 5-12% of the population, are the second most common musculoskeletal pain conditions after chronic low back pain, and are associated with management costs of over $4 billion per year, presenting a serious public health issue. Specialized multidisciplinary care combining dental care with psychological interventions appears to offer the best prognosis. Physical self- regulation (PSR) is a brief, two-session psychological intervention that has been shown to lead to long-term reductions in pain intensity over standard dental care alone in patients with chronic MMPD. Unfortunately, treatment utilization for PSR is low when it is offered in-person, with fewer than 50% of eligible patients choosing to begin treatment. Offering PSR over telehealth (PSR-TH) may help address this issue, with preliminary data demonstrating >80% treatment utilization for PSR-TH. A full-scale Stage 2 trial is needed to test the efficacy of PSR-TH and 1) determine if PSR-TH effects are due to the intervention itself or to nonspecific treatment effects and 2) determine moderators and mediators of treatment effects. However, additional Stage 1 data are needed before such a Stage 2 trial can be conducted. The goal of this proposal is to obtain data to support a future full- scale Stage 2 trial by achieving the following specific aims. First, PSR-TH and a control intervention need to be formally piloted in patients with MMPD to determine recruitment and retention rates, interventionist fidelity, and patient-reported acceptability, credibility, and burden of the interventions (Aim 1). Second, we need to identify potential moderators and mediators associated with treatment success to PSR-TH so that we can focus on thoroughly assessing those specific variables in the future trial (Aim 2). Treatment-seeking patients with chronic MMPD will be randomly assigned to two 50-min telehealth sessions of either PSR-TH or a control intervention (N=54/condition) and provide biopsychosocial data ¬at baseline (for moderation analyses), treatment feasibility and mediator data immediately following the intervention, and outcome data (pain intensity, pain interference, and quality of life 3 months following the intervention). We hypothesize both interventions will demonstrate feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). We also hypothesize that specific biopsychosocial variables at baseline will moderate PSR-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, clenching awareness and relaxation will mediate treatment effects. In addition to providing strong support data for a future full-scale Stage 2 trial of PSR-TH, the proposed project will leverage my previous training, a collaborative environment at the University of Kentucky, and the expertise of world- renown mentors to provide me training in clinical research, assessment of moderators and mediators in orofacial pain, and leadership of large research teams, giving me the skills for a successful career as an independent clinical researcher.