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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
Sponsor:
Information provided by (Responsible Party):
Beth Darnall, Stanford University

Brief Summary:
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.

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

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 231 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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 [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.


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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Axial low back pain without radicular symptoms
  • 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:

  • Gross cognitive impairment
  • 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

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University, Systems Neuroscience and Pain Lab
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Beth Darnall, PhD Stanford University
Principal Investigator: Sean Mackey, MD, PhD Stanford University
Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beth Darnall, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03167086    
Other Study ID Numbers: R01AT008561 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms