Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT03167086
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Study Start: 2017-06-08
• Primary Completion: 2020-06-25
• Study Completion: 2020-08-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Trait Pain Catastrophizing (Trait PC)	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

Name	Time	Method
Trait PC at 6 months Post-treatment	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	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	Several time frames from baseline to 3 months Post-Treatment	Change in activity \& sleep measures from baseline to post-treatment across all treatment groups

Trial Locations

Locations (1)

Stanford University, Systems Neuroscience and Pain Lab; 🇺🇸 Palo Alto, California, United States