Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

NCT03167086 | Completed DMC

• 1 other identifier: R01AT008561
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Trait PC at 6 months Post-treatment

  6 months Post-Treatment

• PROMIS Measures at 3 months Post-treatment

  3 months Post-Treatment

• Actigraphy for function and sleep

  Several time frames from baseline to 3 months Post-Treatment

Study Arms (3)

Single Session Skills-Based Pain Psychology Class

EXPERIMENTAL

"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain.

Behavioral: "Empowered Relief" (ER)

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total).

Behavioral: Cognitive Behavioral Therapy (CBT)

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.

Behavioral: Health Education (HE)

Interventions

"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.

Single Session Skills-Based Pain Psychology Class

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.

Cognitive Behavioral Therapy (CBT)

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.

Health Education (HE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, Systems Neuroscience and Pain Lab

Palo Alto, California, 94304, United States

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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. doi: 10.1001/jamanetworkopen.2022.9739.

  PMID: 34398206 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.

  PMID: 29510735 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Beth Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sean Mackey, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal Investigators and Statisticians performing analyses will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: June 8, 2017
• Primary Completion: June 25, 2020
• Study Completion: August 18, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)