Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Empowered Relief Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Empowered Relief (ER)
* Behavioral: Cognitive Behavioral Therapy (CBT)
* Behavioral: Health Education (HE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Session Skills-Based Pain Psychology Class<br>Empowered Relief (ER): A single-session skills-based approximately 2-hr group intervention for chronic pain. | Behavioral: Empowered Relief (ER)<br>* 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.<br>|
| Active Comparator: Cognitive Behavioral Therapy (CBT)<br>8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* 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.<br>|
| Active Comparator: Health Education (HE)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trait PC at 6 months Post-treatment | Change in Trait Pain Catastrophizing (Trait PC) from baseline to 6 months post-treatment across all treatment groups | 6 months Post-Treatment | 
| PROMIS Measures at 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 | 3 months Post-Treatment | 
| Actigraphy for function and sleep | Change in activity & sleep measures from baseline to post-treatment across all treatment groups | Several time frames from baseline to 3 months Post-Treatment |