Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial
العنوان: | Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial |
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المؤلفون: | Abby L Chen, Beth D. Darnall, Tyler Winslow, Sean Mackey, Maisa S. Ziadni |
المصدر: | Trials Trials, Vol 21, Iss 1, Pp 1-12 (2020) |
بيانات النشر: | Springer Science and Business Media LLC, 2020. |
سنة النشر: | 2020 |
مصطلحات موضوعية: | medicine.medical_specialty, Prescription Drugs, Cognitive-behavioral therapy, medicine.medical_treatment, Prescription opioids, Psychological intervention, Medicine (miscellaneous), Chronic pain, Context (language use), California, law.invention, Behavioral Medicine, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Patient Education as Topic, Randomized controlled trial, law, Humans, Pain Management, Medicine, Pharmacology (medical), 030212 general & internal medicine, Pain catastrophizing, Pain Measurement, Randomized Controlled Trials as Topic, lcsh:R5-920, Cognitive Behavioral Therapy, business.industry, Catastrophization, Pain Perception, medicine.disease, Analgesics, Opioid, Treatment, Cognitive behavioral therapy, Clinical trial, Opioid, Physical therapy, lcsh:Medicine (General), business, 030217 neurology & neurosurgery, medicine.drug |
الوصف: | Background Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including the need for prescription opioids. Given the inherently distressing nature of chronic pain, there is a need to equip individuals with pain education and self-regulatory skills that are shown to improve adaptation and improve their response to medical treatments. Brief, targeted behavioral medicine interventions may efficiently address the key individual factors, improve self-regulation in the context of pain, and reduce the need for opioid therapy. This highlights the critical need for targeted, cost-effective interventions that efficiently address the key psychological factors that can amplify the need for opioids and increased risk for misuse. In this trial, the primary goal is to test the comparative efficacy of a single-session skills-based pain management class to a health education active control group among patients with chronic pain who are taking opioids. Methods/design Our study is a randomized, double-blind clinical trial testing the superiority of our 2-h, single-session skills-based pain management class against a 2-h health education class. We will enroll 136 adult patients with mixed-etiology chronic pain who are taking opioid prescription medication and randomize 1:1 to one of the two treatment arms. We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent. Team researchers masked to treatment assignment will assess outcomes up to 12 months post treatment. Discussion This study aims to test the utility of a single-session, 2-h skills-based pain management class to improve self-regulation of pain and reduce opioid use. Findings from our project have the potential to shift current research and clinical paradigms by testing a brief and scalable intervention that could reduce the need for opioids and prevent misuse effectively, efficiently, and economically. Further, elucidation of the mechanisms of opioid use can facilitate refinement of more targeted future treatments. Trial registration ClinicalTrials.gov, ID: NCT03950791. Registered on 10 May 2019. |
تدمد: | 1745-6215 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6f71ea92133ffb91a884d3748f169cfd https://doi.org/10.1186/s13063-020-04415-x |
حقوق: | OPEN |
رقم الأكسشن: | edsair.doi.dedup.....6f71ea92133ffb91a884d3748f169cfd |
قاعدة البيانات: | OpenAIRE |
تدمد: | 17456215 |
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