Virtual Empowered Relief for Chronic Pain
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|ClinicalTrials.gov Identifier: NCT05057988|
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : August 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Pain||Behavioral: Empowered Relief class||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single intervention|
|Masking:||None (Open Label)|
|Official Title:||Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine|
|Actual Study Start Date :||September 8, 2021|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||December 30, 2023|
|Experimental: Empowered Relief||
Behavioral: Empowered Relief class
The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
- Perceived usefulness/utility [ Time Frame: once immediately after class ]How useful was the information presented in the class?
- Participant satisfaction [ Time Frame: once immediately after class ]Please rate your overall satisfaction with the class
- Likelihood of using the skills [ Time Frame: once immediately after class ]How likely are you to use the skills and information you learned?
- Pain Bothersomness [ Time Frame: At 1 month post-tx ]How "bothersome" your pain had been during the previous week?
- PCS total scores [ Time Frame: At 1 month post-tx ]The Pain Catastrophizing Scale total scores
- Pain Intensity [ Time Frame: At 1 month post-tx ]How would you rate your pain on average in the past 7 days?
- Sleep disturbance [ Time Frame: At 1 month post-tx ]PROMIS-Sleep Disturbance short form T scores
- Pain interference [ Time Frame: At 1 month post-tx ]PROMIS-Pain Interference short form T scores
- Depression [ Time Frame: At 1 month post-tx ]PROMIS-Depression short form T scores
- Anxiety [ Time Frame: At 1 month post-tx ]PROMIS-Anxiety short form T scores
- Physical Function [ Time Frame: At 1 month post-tx ]PROMIS-Physical Function short form T Scores
- Global Impression of change [ Time Frame: At 1 month post-tx ]The global impression of change
- Craving [ Time Frame: At 1 month post-tx ]How much do you crave opiates now?
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age at least 18 years old
- Chronic Pain (> 3 months)
- Taking Methadone or Buprenorphine
- English Fluency
- Gross Cognitive Impairment,
- Acute Suicidality,
- Severe Depression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05057988
|Contact: Dokyoung S You, PhDfirstname.lastname@example.org|
|United States, California|
|Stanford Pain Relief Innovations Lab||Recruiting|
|Palo Alto, California, United States, 27604|
|Contact: Dokyoung S You, PhD|
|Responsible Party:||Beth Darnall, Associate Professor, Stanford University|
|Other Study ID Numbers:||
|First Posted:||September 27, 2021 Key Record Dates|
|Last Update Posted:||August 3, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|