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Completed

NCT Number: NCT03167086

Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Systems Neuroscience and Pain Lab

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Empowered Relief" (ER)

Behavioral

"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.

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Health Education (HE)

Behavioral

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.

Primary outcomes

  1. Trait Pain Catastrophizing (Trait PC)

    Time frame: 3 months Post-Treatment

    Change in Trait Pain Catastrophizing (Trait PC) from baseline to 3 months post-treatment across all treatment groups

Secondary outcomes

  1. Trait PC at 6 months Post-treatment

    Time frame: 6 months Post-Treatment

    Change in Trait Pain Catastrophizing (Trait PC) from baseline to 6 months post-treatment across all treatment groups

  2. PROMIS Measures at 3 months Post-treatment

    Time frame: 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. Actigraphy for function and sleep

    Time frame: Several time frames from baseline to 3 months Post-Treatment

    Change in activity & sleep measures from baseline to post-treatment across all treatment groups

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 25, 2017
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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