Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03167086|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2017
Last Update Posted : April 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Behavioral: "Empowered Relief" (ER) Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Health Education (HE)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||231 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Principal Investigators and Statisticians performing analyses will be blinded.|
|Official Title:||"Empowered Relief" Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms|
|Actual Study Start Date :||June 8, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Single Session Skills-Based Pain Psychology Class
"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain.
Behavioral: "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.
Active Comparator: Cognitive Behavioral Therapy (CBT)
8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total).
Behavioral: 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 .
Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk & Winter  for optional reading.
Active Comparator: 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.
Behavioral: 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.
- Trait Pain Catastrophizing (Trait PC) [ Time Frame: 3 months Post-Treatment ]Change in Trait Pain Catastrophizing (Trait PC) from baseline to 3 months post-treatment across all treatment groups
- Trait PC at 6 months Post-treatment [ Time Frame: 6 months Post-Treatment ]Change in Trait Pain Catastrophizing (Trait PC) from baseline to 6 months post-treatment across all treatment groups
- PROMIS Measures at 3 months Post-treatment [ Time Frame: 3 months Post-Treatment ]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
- Actigraphy for function and sleep [ Time Frame: Several time frames from baseline to 3 months Post-Treatment ]Change in activity & sleep measures from baseline to post-treatment across all treatment groups
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): NCT03167086
|United States, California|
|Stanford University, Systems Neuroscience and Pain Lab|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Beth Darnall, PhD||Stanford University|
|Principal Investigator:||Sean Mackey, MD, PhD||Stanford University|