Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
- Conditions
- Chronic Low Back Pain
- Interventions
- Behavioral: Health Education (HE)Behavioral: "Empowered Relief" (ER)Behavioral: Cognitive Behavioral Therapy (CBT)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- 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
- 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
- Arm && Interventions
Group Intervention Description Health Education (HE) 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. Single Session Skills-Based Pain Psychology Class "Empowered Relief" (ER) "Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain. Cognitive Behavioral Therapy (CBT) Cognitive Behavioral Therapy (CBT) 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total).
- 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