Chronic Low Back Pain
Conditions
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.
Interventions
BEHAVIORALEmpowered 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.
BEHAVIORALCognitive 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.
BEHAVIORALHealth 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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Principal Investigators and Statisticians performing analyses will be blinded.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed