Skills Training and Relief for Orofacial Pain

Conditions

• Immediate Intervention
• Waitlist Control

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empowered Relief — BEHAVIORAL
  Empowered Relief (ER) is a single-session, 2-hour pain management course designed with the purpose of assisting individuals with chronic pain to gain skills for self-pain management. ER is taught through a PowerPoint presentation which includes pain education, self-regulatory skills (i.e., relaxation, cognitive reframing, and self-soothing), and mindfulness skills, all grounded in pain-CBT theory (Darnall et al., 2021). The intervention will be delivered by a certified Empowered Relief instructor.

Study Details

Chronic orofacial pain conditions (COFP) are associated with substantial physical and psychological burden and are best treated with multidisciplinary approaches combining psychological interventions and comprehensive orofacial pain care. Yet, important barriers prevent access to psychological interventions for COFP (e.g., lack of providers, financial resources). This study will assess the feasibility and acceptability of adapting a single two-hour telehealth-delivered group course, Empowered Relief (ER), which was created for heterogenous chronic pain condition, into a multidisciplinary COFP clinic. ER addresses many existing barriers to assessing psychological interventions for COFP as it is deliverable via telehealth, in a group format, within a single session. This study hypothesizes that ER will demonstrate adequate feasibility and acceptability among patients with COFP. Participants will be recruited over a 6-month period from patients evaluated for an initial appointment at the University of Kentucky Orofacial Pain Clinic (UKOPC). A randomized waitlist control design will be used to inform a future efficacy trial. Specifically, new patients seeking an initial appointment at the UKOPC will be introduced to the study, and if they consent, they will be randomly assigned to participate in the next available ER course (i.e., immediate group) or the ER course offered the subsequent month (i.e., waitlist control group). All participants will provide feasibility and acceptability data after receiving the intervention. Those assigned to immediate group will provide biopsychosocial functioning and outcome data at one, two, and four weeks following the pain course. Those assigned to the immediate control group will provide data one, two, and four weeks before the intervention for a comparison group. Data from this study will inform design decisions for a future efficacy trial.

Key Dates

First listed

Sep 3, 2026

Start date

Oct 1, 2026

Status verified

Aug 2026

Primary completion

Oct 1, 2027

Completion

Oct 1, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Immediate Intervention
  Participants in this arm will be scheduled to partake in the next available Empowered Relief course
• No Intervention: Waitlist Control
  Participants in this arm will be scheduled to partake in the Empowered Relief course approximately 1 month after they consent for the study

Primary Outcome Measure

Recruitment Rate [ Time Frame: Baseline (week 0) ]

Central Contacts

• Kathleen E Wakeman, M.S.
  508-759-8037
  [email protected]

Locations (1)

Find similar trials in Lexington, KY

Related Studies

• Effects of Youth Mental Health First Aid (YMHFA) on South Asian American Adults Working With South Asian American Youth
  Enrolling By Invitation · University of Maryland, College Park · College Park, Maryland