K23- Physical Self Regulation vs Placebo for Temporomandibular Disorder
This study is testing two different telehealth-delivered behavioral interventions for chronic temporomandibular disorder (TMD), specifically chronic masticatory muscle pain. You might be able to join if you are 18 or older, speak and write English, and have a diagnosis of chronic masticatory muscle pain. The study will compare "Physical Self Regulation Telehealth," which teaches awareness and exercises, with "Psycho-education Telehealth," which discusses jaw anatomy, pain, and stress. Researchers will look at changes in your pain intensity, how much pain interferes with your daily life, and your quality of life at 5 weeks and 3 months after the interventions. The current recruitment status is unclear.
- Study design
- This study is designed to compare two different behavioral interventions. About 104 participants will be randomly assigned to receive either Physical Self Regulation Telehealth or Psycho-education Telehealth.
- What's involved
- You would participate in two 50-minute telehealth sessions, scheduled about two weeks apart. You would also provide follow-up data two weeks and three months after your interventions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for three months after completing the interventions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
K23- Physical Self Regulation vs Placebo
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ian Boggero, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in pain intensityBaseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Pain intensity will be measured with the Graded Chronic Pain Scale Pain Intensity Subscale. Participants rate their worst pain, least pain, average pain, in the last 24 hours and pain right now using an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater pain. Scores are averaged for the total pain intensity score.
- Change in pain interferenceBaseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Pain interference will be measured with the The Graded Chronic Pain Scale Pain Interference Subscale. Participants rate how much the pain has interfered with 7 daily activities on an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater interference. Pain interference is scored as the mean of the 7 items.
- Change in quality of lifeBaseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
Quality of life will be measured with the Satisfaction with Life Scale. Likert scale with 7 items scores range from 7 to 35 with higher scores equating to better quality of life.
- Recruitment rateBaseline (week 0)
Number of patients who are consented into the study per month
- Retention rateFollow up Visit at Month 3 (week 15)
Number of consented patients who also complete the three-month follow-up assessment
- Interventionist Fidelity Session 1Study Visit 1 (week 1)
Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage: Total items covered by interventionist/ Total possible items to be covered in that session
- Interventionist Fidelity Session 2Study Visit 2 (week 3)
Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage: Total items covered by interventionist/ Total possible items to be covered in that session
- Treatment AcceptabilityStudy Visits 1 and 2 (up to 2 weeks)
Treatment Acceptability and Adherence Scale. The scale will measure what participants overall evaluation of if treatment was fair, reasonable, and appropriate. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater acceptability. Acceptability is scored as the mean of the 6 items.
- Treatment CredibilityStudy Visits 1 and 2 (up to 2 weeks)
Treatment Credibility/Expectancy Scale will measure how feasible is it the intervention will work and work for the participant. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater credibility. Acceptability is scored as the mean of the 6 items.
- Research BurdenFollow up Visit at Month 3 (week 15)
Research burden will be measured by administering 8 selected items from the Perceived Research Burden Assessment. Participants rate how burdensome the study was on an 8 item assessment on a 5 point Likert scale ranging from strongly disagree to strongly agree with higher scores equating to greater burden. Burden is scored as mean of the 8 items.