Feasibility and Acceptability of OLP-EXP in Chronic Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

The primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of prescribed days in each OLP arm.

Primary hypothesis: Each intervention arm will meet the prespecified 6-week retention benchmark, and each OLP arm will meet the prespecified pill-adherence benchmark.

The secondary objectives are:

1. To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews. 2. To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments. 3. To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial. 4. To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.

Eligibility criteria

Qualifiers

English speaking (written and spoken)

Age between 18 and 65 years

Confirmed TMD for more than 3 months

Grade II or above on the Graded Chronic Pain Scale

Disqualifiers

Personal (or family first degree) history of mania, schizophrenia, or other psychoses

Severe psychiatric conditions require medication (e.g. schizophrenia, bipolar disorders, autism) or hospitalization within the last 3 years.

Lifetime alcohol/drug dependence and alcohol/drug abuse in past one year

Pregnancy/Breastfeeding

Trial design

Treatments tested in this trial

  • OLP-EXP
  • OLP
  • EXP

Treatment groups

57 Participants
are divided into 3 treatment groups

Locations

This trial has no locations