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This study aims to compare the efficacy of a single session psychological treatment, "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores.
This is a randomized 3-arm study comprised of 2 active psychological treatments (ER & CBT) and a health education (HE) arm that controls for time and attention. Study goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the current gold standard group treatment for PC -- manualized 8-session pain-CBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Session Skills-Based Pain Psychology Class | Experimental | "Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain. |
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| Cognitive Behavioral Therapy (CBT) | Active Comparator | 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). |
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| Health Education (HE) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Empowered Relief" (ER) | Behavioral | "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. |
| Measure | Description | Time Frame |
|---|---|---|
| Trait Pain Catastrophizing (Trait PC) | Change in Trait Pain Catastrophizing (Trait PC) from baseline to 3 months post-treatment across all treatment groups | 3 months Post-Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Trait PC at 6 months Post-treatment | Change in Trait Pain Catastrophizing (Trait PC) from baseline to 6 months post-treatment across all treatment groups | 6 months Post-Treatment |
| PROMIS Measures at 3 months Post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Darnall, PhD | Stanford University | Principal Investigator |
| Sean Mackey, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, Systems Neuroscience and Pain Lab | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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). | ||
| Background | 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). | ||
| Background | 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. | ||
| Background | 4. Turk, D.C., Winter, F., The Pain Survival Guide: How to reclaim your life. 2005, Washington, D.C.: American Psychological Association. | ||
| 34398206 |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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The design is a randomized 3-arm study comprised of 2 active psychological treatments (ER & CBT) and a health education (HE) arm that controls for time and attention.
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Principal Investigators and Statisticians performing analyses will be blinded.
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| Cognitive Behavioral Therapy (CBT) | Behavioral | 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. |
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| Health Education (HE) | Behavioral | 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. |
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Change in score of PROMIS domains for chronic pain - including pain intensity, physical functioning, and emotional functioning - from baseline to post-treatment 3 months across all three treatment groups
| 3 months Post-Treatment |
| Actigraphy for function and sleep | Change in activity & sleep measures from baseline to post-treatment across all treatment groups | Several time frames from baseline to 3 months Post-Treatment |
| Derived |
| 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. |
| 29510735 | Derived | 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. |