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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have a primary or secondary chronic masticatory muscle pain diagnosis

• Provide signed and dated electronic informed consent form

• Willing to comply with all study procedures

• Male or female, aged 18 or over

• Be able to speak and write in English

• Be seeking treatment at UKOPC

• Have the ability to perform telehealth visits (i.e., internet access, phone, tablet, computer or other device with audio/visual capabilities)

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Courtney Brown
cbrown@uky.edu
8593230246
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 104
Treatments
Experimental: Physical Self Regulation
2 experimental telehealth sessions approximately 2 weeks apart
Active_comparator: Psycho-education
2 control telehealth sessions approximately 2 weeks apart
Related Therapeutic Areas
Sponsors
Leads: Ian Boggero, PhD
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

This content was sourced from clinicaltrials.gov