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Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

"Empowered Relief" (ER)

Cognitive Behavioral Therapy (CBT)

Health Education (HE)

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Stanford University, Systems Neuroscience and Pain Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Single Session Skills-Based Pain Psychology Class

Cognitive Behavioral Therapy (CBT)

Health Education (HE)

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Trait Pain Catastrophizing (Trait PC)

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

Secondary Outcome Measures

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

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

Actigraphy for function and sleep

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

Full Information

NCT ID

NCT03167086

First Posted

May 22, 2017

Last Updated

October 19, 2020

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03167086

Brief Title

Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

June 8, 2017 (Actual)

Primary Completion Date

June 25, 2020 (Actual)

Study Completion Date

August 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

InvestigatorOutcomes Assessor

Masking Description

Principal Investigators and Statisticians performing analyses will be blinded.

Allocation

Randomized

Enrollment

263 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Session Skills-Based Pain Psychology Class

Arm Type

Experimental

Arm Description

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

Arm Title

Cognitive Behavioral Therapy (CBT)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Health Education (HE)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

"Empowered Relief" (ER)

Intervention Description

"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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy (CBT)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Health Education (HE)

Intervention Description

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 Outcome Measure Information:

Title

Trait Pain Catastrophizing (Trait PC)

Description

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

Time Frame

3 months Post-Treatment

Secondary Outcome Measure Information:

Title

Trait PC at 6 months Post-treatment

Description

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

Time Frame

6 months Post-Treatment

Title

PROMIS Measures at 3 months Post-treatment

Description

Time Frame

3 months Post-Treatment

Title

Actigraphy for function and sleep

Description

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

Time Frame

Several time frames from baseline to 3 months Post-Treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beth Darnall, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sean Mackey, MD, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University, Systems Neuroscience and Pain Lab

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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).

Results Reference

background

Citation

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).

Results Reference

background

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

34398206

Citation

Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739.

Results Reference

derived

PubMed Identifier

29510735

Citation

Darnall BD, Ziadni MS, Roy A, Kao MC, Sturgeon JA, Cook KF, Lorig K, Burns JW, Mackey SC. Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Trials. 2018 Mar 6;19(1):165. doi: 10.1186/s13063-018-2537-3.

Results Reference

derived

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Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

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