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Study protocol
Maisa Ziadni
Stanford University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8371-0646
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including 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 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 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: Our study is a randomized, double-blind clinical trial testing the superiority of our 2-hour single-session skills-based pain management class against a 2-hour 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-hour 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 need for opioids and prevent misuse effectively, efficiently and economically. Further, elucidation of mechanisms of opioid use can facilitate refinement of more targeted future treatments.
Keywords
Chronic pain, prescription opioids, pain catastrophizing, cognitive-behavioral therapy, behavioral medicine, treatment
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CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 02 Apr, 2020
No community comments so far
Review #1 received
Received 15 Apr, 2020
Editorial decision: Major revision
On 15 Apr, 2020
Reviewers invited
Invitations sent on 12 Apr, 2020
Reviewer #1 agreed
On 12 Apr, 2020
Editor assigned
On 07 Apr, 2020
Submission checks complete
On 31 Mar, 2020
First submitted
On 28 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Anesthesiology & Pain Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Maisa Ziadni
Stanford University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8371-0646
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 02 Apr, 2020
No community comments so far
Review #1 received
Received 15 Apr, 2020
Editorial decision: Major revision
On 15 Apr, 2020
Reviewers invited
Invitations sent on 12 Apr, 2020
Reviewer #1 agreed
On 12 Apr, 2020
Editor assigned
On 07 Apr, 2020
Submission checks complete
On 31 Mar, 2020
First submitted
On 28 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Anesthesiology & Pain Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including 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 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 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: Our study is a randomized, double-blind clinical trial testing the superiority of our 2-hour single-session skills-based pain management class against a 2-hour 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-hour 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 need for opioids and prevent misuse effectively, efficiently and economically. Further, elucidation of mechanisms of opioid use can facilitate refinement of more targeted future treatments.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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