Study Summary
This trial is testing a single-session pain management class to see if it's effective for patients with chronic pain who take methadone or buprenorphine. The class covers self-regulatory skills and participants make a personalized plan to use the skills every day. The trial will test feasibility, satisfaction, and whether the class confers short-term and medium-term benefits.
- Chronic Pain
- Pain
- Opioid Use Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: At 1 month post-tx
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Empowered Relief
1 of 1
Experimental Treatment
75 Total Participants · 1 Treatment Group
Primary Treatment: Empowered Relief class · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- Darnall, Beth, John Sturgeon, Ming-Chih Kao, Jennifer Hah, and Sean Mackey. 2014. “From Catastrophizing to Recovery: A Pilot Study of a Single-session Treatment for Pain Catastrophizing”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s62329.
- Darnall, Beth D., Anuradha Roy, Abby L. Chen, Maisa S. Ziadni, Ryan T. Keane, Dokyoung S. You, Kristen Slater, et al.. 2021. “Comparison of a Single-session Pain Management Skills Intervention with a Single-session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults with Chronic Low Back Pain”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.13401.
- Ziadni, Maisa S., Steven R. Anderson, Lluvia Gonzalez-Castro, and Beth D. Darnall. 2021. “Comparative Efficacy of a Single-session “empowered Relief” Videoconference-delivered Group Intervention for Chronic Pain: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05303-8.
- Darnall, Beth D., Anuradha Roy, Abby L. Chen, Maisa S. Ziadni, Ryan T. Keane, Dokyoung S. You, Kristen Slater, et al.. 2021. “Comparison of a Single-session Pain Management Skills Intervention with a Single-session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults with Chronic Low Back Pain”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.13401.
- Darnall, Beth D., Anuradha Roy, Abby L. Chen, Maisa S. Ziadni, Ryan T. Keane, Dokyoung S. You, Kristen Slater, et al.. 2021. “Comparison of a Single-session Pain Management Skills Intervention with a Single-session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults with Chronic Low Back Pain”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.13401.
- Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739.
- Beth Darnall 2021. "Virtual Empowered Relief for Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05057988.
Frequently Asked Questions
Is this experiment actively recruiting participants?
"Affirmative. Clinicaltrials.gov displays that this research initiative, which was first posted on September 8th 2021, is now recruiting participants. Approximately 75 patients are needed at 1 site." - Anonymous Online Contributor
How many participants can the trial accommodate at its highest capacity?
"Affirmative. According to the data published on clinicaltrials.gov, this trial is actively looking for enrollees; it was first posted on September 8th 2021 and has most recently been updated August 1st 2022. 75 people need to be recruited from a single centre." - Anonymous Online Contributor
What tangible goals are researchers aiming to accomplish with this clinical trial?
"The primary metric of evaluation for this research is the participant's satisfaction which will be assessed shortly after each session. Secondary objectives include sleep disturbance (rated via PROMIS-Sleep Disturbance short form T scores), pain intensity, and pain bothersomeness (both rated from a scale spanning 1 to 7 days)." - Anonymous Online Contributor