protocolSection identificationModule nctId: NCT06357702, orgStudyIdInfo id: 81313, secondaryIdInfos id: K23DE031807, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DE031807, briefTitle: K23- Physical Self Regulation vs Placebo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ian Boggero, PhD, class: OTHER, collaborators name: National Institute of Dental and Craniofacial Research (NIDCR), descriptionModule briefSummary: This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators 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). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-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., conditionsModule conditions: Temporomandibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Physical Self Regulation Telehealth, interventions name: Psycho-education Telehealth, outcomesModule primaryOutcomes measure: Change in pain intensity, primaryOutcomes measure: Change in pain interference, primaryOutcomes measure: Change in quality of life, primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Interventionist Fidelity Session 1, primaryOutcomes measure: Interventionist Fidelity Session 2, primaryOutcomes measure: Treatment Acceptability, primaryOutcomes measure: Treatment Credibility, primaryOutcomes measure: Research Burden, secondaryOutcomes measure: Treatment Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40506, country: United States, contacts name: Ian Boggero, Ph.D., role: CONTACT, phone: 859-562-3291, email: ian.boggero@uky.edu, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False