Clinical trial NCT03167086: Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
Official title: "Empowered Relief" Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Trait Pain Catastrophizing (Trait PC)
timeFrame: 3 months Post-Treatment
Secondary outcomes:
measure: Trait PC at 6 months Post-treatment
timeFrame: 6 months Post-Treatment
measure: PROMIS Measures at 3 months Post-treatment
timeFrame: 3 months Post-Treatment
measure: Actigraphy for function and sleep
timeFrame: Several time frames from baseline to 3 months Post-Treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, Systems Neuroscience and Pain Lab
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Sean Mackey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).
citation: 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).
citation: 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.
citation: 4. Turk, D.C., Winter, F., The Pain Survival Guide: How to reclaim your life. 2005, Washington, D.C.: American Psychological Association.
citation: 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.
citation: 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.