Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

• ClinicalTrials.gov Identifier: NCT03167086
• Recruitment Status: Completed
• First Posted: May 25, 2017
• Last Update Posted: October 20, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Beth Darnall, Stanford University

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 263 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
• Actual Primary Completion Date: June 25, 2020
• Actual Study Completion Date: August 18, 2020

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Stanford University, Systems Neuroscience and Pain Lab

Palo Alto, California, United States, 94304

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Beth Darnall, PhD; Stanford University
• Principal Investigator: Sean Mackey, MD, PhD; Stanford University

More Information

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):

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. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739.

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.

• 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
• Last Update Posted: October 20, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Low Back Pain; Back Pain; Pain; Neurologic Manifestations