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Single Session Pain Catastrophizing Treatment: Comparative Efficacy & Mechanisms

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ClinicalTrials.gov Identifier: NCT03167086
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Beth Darnall, Stanford University

Brief Summary:
This study aims to compare the efficacy of a single session psychological treatment, "From Catastrophizing to Recovery" (FCR), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain suffering from Pain Catastrophizing (PC).

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: "From Catastrophizing to Recovery" (FCR) Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Health Education (HE) Not Applicable

Detailed Description:
This is a randomized 3-arm study comprised of 2 active psychological treatments (FCR & 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 FCR, and also provide a comparison of said efficacy against the current gold standard group treatment for PC -- manualized 8-session pain-CBT.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The design is a randomized 3-arm study comprised of 2 active psychological treatments (FCR & CBT) and a health education (HE) arm that controls for time and attention.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Principal Investigators and Statisticians performing analyses will be blinded.
Primary Purpose: Treatment
Official Title: Single Session Pain Catastrophizing Treatment: Comparative Efficacy & Mechanisms
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Single Session Pain Psychology Class
"From Catastrophizing to Recovery (FCR)": A single-session approximately 2-hr group intervention to treat pain catastrophizing (PC).
Behavioral: "From Catastrophizing to Recovery" (FCR)

"From Catastrophizing to Recovery (FCR)": A single-session approximately 2-hr group intervention to treat PC.

Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the FCR sessions.

Content of intervention: FCR Participants have the 'FCR Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device.


Active Comparator: Cognitive Behavioral Therapy (CBT)
8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total).
Behavioral: 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.


Active Comparator: Health Education (HE)
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 (FCR) on 4 important factors: duration, structure, format and site.
Behavioral: 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 FCR 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

****Please visit the website to see if you are eligible: bit.ly/painreliefstudy ******


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167086


Contacts
Contact: Beth Darnall, PhD 650-724-2811 bdarnall@stanford.edu
Contact: Anuradha Roy, MSc 650-724-2811 anuroy@stanford.edu

Locations
United States, California
Stanford University, Systems Neuroscience and Pain Lab Recruiting
Palo Alto, California, United States, 94304
Contact: Anu Roy, MSc       anuroy@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Beth Darnall, PhD Stanford University
Principal Investigator: Sean Mackey, MD, PhD Stanford University

Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beth Darnall, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03167086     History of Changes
Other Study ID Numbers: R01AT008561 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms