Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Stanford University

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Behavioral: Health Education (HE); Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: "Empowered Relief" (ER)

Study type: Interventional

Funder types: Other

Identifiers

NCT03167086

R01AT008561

Details and patient eligibility

About

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.

Full 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.

Enrollment: 263 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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263 participants in 3 patient groups

Single Session Skills-Based Pain Psychology Class

Experimental group

Description:

"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain.

Treatment:

Behavioral: "Empowered Relief" (ER)

Cognitive Behavioral Therapy (CBT)

Active Comparator group

Description:

8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total).

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Health Education (HE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education (HE)