Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
NCT ID: NCT03167086
Last Updated: 2020-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
263 participants
INTERVENTIONAL
2017-06-08
2020-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Single Session Skills-Based Pain Psychology Class
"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain.
"Empowered Relief" (ER)
"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention to treat chronic pain.
Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the ER sessions.
Content of intervention: ER Participants have the 'ER Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device.
Cognitive Behavioral Therapy (CBT)
8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total).
Cognitive Behavioral Therapy (CBT)
Format of intervention: 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). The group is run weekly for 8 consecutive classes. Each class is 2 hours with a midpoint break (16 hours total intervention time).
Content of intervention: The protocol and materials were developed with funding from NIH/NCCAM R01 AT006226 (Dan Cherkin, PI) \[1\& 2\], and include content from a pain-CBT program developed by Drs. Ehde, Dillworth, and Turner \[3\].
Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk \& Winter \[4\] for optional reading.
Health Education (HE)
The active control treatment arm consists only of Health Education and has no psychological treatment components. It is a 2-hour HE class matched to the single-session psychological experimental arm (ER) on 4 important factors: duration, structure, format and site.
Health Education (HE)
Format of intervention: The HE class will be instructor taught and will involve a PowerPoint presentation and handouts. Two additional providers will be identified and trained to conduct the sessions. Selected instructors will have substantial health education experience.
Content of intervention: HE content will include basic information such as nutrition and interacting with the healthcare system; these relatively 'inert' topics are unlikely to impart any specific effects typically found with a true psychobehavioral intervention.
Interventions
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"Empowered Relief" (ER)
"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention to treat chronic pain.
Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the ER sessions.
Content of intervention: ER Participants have the 'ER Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device.
Cognitive Behavioral Therapy (CBT)
Format of intervention: 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). The group is run weekly for 8 consecutive classes. Each class is 2 hours with a midpoint break (16 hours total intervention time).
Content of intervention: The protocol and materials were developed with funding from NIH/NCCAM R01 AT006226 (Dan Cherkin, PI) \[1\& 2\], and include content from a pain-CBT program developed by Drs. Ehde, Dillworth, and Turner \[3\].
Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk \& Winter \[4\] for optional reading.
Health Education (HE)
Format of intervention: The HE class will be instructor taught and will involve a PowerPoint presentation and handouts. Two additional providers will be identified and trained to conduct the sessions. Selected instructors will have substantial health education experience.
Content of intervention: HE content will include basic information such as nutrition and interacting with the healthcare system; these relatively 'inert' topics are unlikely to impart any specific effects typically found with a true psychobehavioral intervention.
Eligibility Criteria
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Inclusion Criteria
* Pain duration ≥ 6 months (per recent NIH Task Force on Research Standards for Chronic Low Back Pain based on participant self-report
* Average pain intensity ≥4/10 for the past month at screening visit
* English fluency
* Males and females 18-70 years of age
* Pain Catastrophizing Score (PCS) ≥20
Exclusion Criteria
* Active suicidal ideation or severe depression
* Previous attendance in the active treatment groups (any ER classes ever taken or CBT in the past 3 years)
* Participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptable
* Current substance abuse
* Clear likelihood to disrupt fellow class participants (e.g., personality disorder) at the discretion of the study team
18 Years
70 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Beth Darnall
Clinical Associate Professor
Principal Investigators
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Beth Darnall, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Sean Mackey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University, Systems Neuroscience and Pain Lab
Palo Alto, California, United States
Countries
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References
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1. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Therapist Manual. 2012, Seattle, WA: Group Health Research Institute. (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal investigator).
2. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Patient Workbook. 2012, Seattle, WA: Group Health Research Institute (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal Investigator).
3. Ehde, D.M., Dillworth, T. M., & Turner, J.A. , Cognitive-Behavioral Therapy Manual for the Telephone-Delivered Intervention for Pain Study (Unpublished treatment manual). 2012.
4. Turk, D.C., Winter, F., The Pain Survival Guide: How to reclaim your life. 2005, Washington, D.C.: American Psychological Association.
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.
Darnall BD, Ziadni MS, Roy A, Kao MC, Sturgeon JA, Cook KF, Lorig K, Burns JW, Mackey SC. Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Trials. 2018 Mar 6;19(1):165. doi: 10.1186/s13063-018-2537-3.
Other Identifiers
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