Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167086
• Other study ID #: R01AT008561
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: August 18, 2020

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: August 18, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• "Empowered 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.
• Cognitive 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.
• Health 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.

Locations

Country	Name	City	State
United States	Stanford University, Systems Neuroscience and Pain Lab	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

1. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Therapist Manual. 2012, Seattle, WA: Group Health Research Institute. (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal investigator).

2. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Patient Workbook. 2012, Seattle, WA: Group Health Research Institute (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal Investigator).

3. Ehde, D.M., Dillworth, T. M., & Turner, J.A. , Cognitive-Behavioral Therapy Manual for the Telephone-Delivered Intervention for Pain Study (Unpublished treatment manual). 2012.

4. Turk, D.C., Winter, F., The Pain Survival Guide: How to reclaim your life. 2005, Washington, D.C.: American Psychological Association.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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