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

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. 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 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 data are needed before such a trial can be conducted. The goal of this proposal is to obtain data to support a future

full-scale Phase II efficacy 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 of PSR-TH so that we can focus on thoroughly assessing those specific variables in the future trial (Aim 2). Treatment-seeking females with chronic MMPD will be randomly assigned to two 50-min telehealth sessions of PSR-TH or a control intervention (N=52/group) and will provide biopsychosocial moderator data (week 0), treatment feasibility data

immediately following the intervention (week 3), mediation data two weeks following the intervention (week 5), and outcome data (pain intensity, pain interference, and quality of life) two weeks and three months following the intervention (weeks 5 and 15). We hypothesize that both PSR-TH and the control intervention will

demonstrate strong 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 will moderate PSR-related changes in outcomes, and that PSR-TH-related changes

in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. In addition to supporting a future efficacy 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 research teams, giving me the skills for a successful independent clinical research career.