Chronic low back pain (CLBP) is the most common chronic pain condition and is the second leading cause of disability in the U.S. Pain catastrophizing (PC)--a pattern of negative cognitive-emotional responses to actual or anticipated pain-is significantly associated with the development and maintenance of CLBP as well as disability. PC undermines CLBP treatments, thus contributing to a cycle of treatment futility and wasted expenditure. While Cognitive Behavioral Therapy (pain-CBT) treats PC, group treatment involves 6-10 sessions and thus poses substantial burdens of time, travel, and cost. Therefore, there is a critical need to develop and disseminate efficient, low-cost treatments that specifically reduce PC. Accordingly, we developed a single-session, 2-hour pain-CBT class that solely treats PC (From Catastrophizing to Recovery; FCR). Our pilot data revealed large effect sizes for FCR in a chronic pain sample and superior outcomes for medical and psychological across PROMIS domains, as compared to a 'treatment as usual' matched clinic cohort. We propose to conduct a 3-arm comparative efficacy RCT in 231 patients with CLBP comparing: (A) FCR, (B) a health education control, and (C) an 8-session pain-CBT class. Our primary endpoint is PC 3 months post- treatment and our secondary endpoint is PC 6 months post-treatment. We hypothesize that FCR will be superior to active control and non-inferior to the 8-session pain-CBT class for improving PC and pain-related outcomes measured by our PROMIS platform. An innovative aspect of the application is our proposal to develop and validate a brief version Daily PCS measure, and apply the measure with high frequency sampling methods to elucidate the mechanics of PC, and to characterize how positive response to active intervention reduces the influence of PC episodes. Additional novel methods our specialized PROMIS platform; actigraphy for objective sleep and activity measurement; and a customized 'FCR Relaxation Resource' app (on Nexus 7 tablets) to objectively quantify skills use in the FCR group. Our rich dataset will allow for detailed phenotyping of responders / non-responders for both active treatments using machine learning and other advanced analytics. We will use daily ratings across a longitudinal timeframe to characterize how PC changes in response to treatment, as well as the mechanistic influence of PC on pain, sleep, activity, and other variables. Our proposal addresses the NCCAM priorities to (1) alleviate chronic pain, (2) study our mind-body intervention in a real-world setting, and (3) advance scientific understanding of the mechanisms of PC.

Public Health Relevance

Pain catastrophizing (PC)--a negative cognitive and emotional psychological pattern-is so powerful that it undermines medical treatment and contributes to pain chronicity. This project investigates a promising single- session, low-cost intervention that specifically treats PC. The concentrated scope and format of the intervention allows for broad patient access and thus may reduce the suffering of millions of Americans living with chronic pain.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project (R01)
Project #
5R01AT008561-03
Application #
9283397
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Weber, Wendy J
Project Start
2015-09-01
Project End
2020-05-31
Budget Start
2017-06-01
Budget End
2018-05-31
Support Year
3
Fiscal Year
2017
Total Cost
$809,323
Indirect Cost
$297,093
Name
Stanford University
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94304
Carriere, Junie S; Sturgeon, John A; Yakobov, Esther et al. (2018) The Impact of Perceived Injustice on Pain-related Outcomes: A Combined Model Examining the Mediating Roles of Pain Acceptance and Anger in a Chronic Pain Sample. Clin J Pain 34:739-747
Ziadni, M S; Sturgeon, J A; Darnall, B D (2018) The relationship between negative metacognitive thoughts, pain catastrophizing and adjustment to chronic pain. Eur J Pain 22:756-762
Darnall, Beth D; Ziadni, Maisa S; Stieg, Richard L et al. (2018) Patient-Centered Prescription Opioid Tapering in Community Outpatients With Chronic Pain. JAMA Intern Med 178:707-708
Darnall, Beth D; Colloca, Luana (2018) Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol 139:129-157
Darnall, Beth D; Ziadni, Maisa S; Roy, Anuradha et al. (2018) Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Trials 19:165
Ziadni, Maisa; You, Dokyoung S; Wilson, Anna C et al. (2018) CARE Scale-7: Development and Preliminary Validation of a Measure to Assess Factors Impacting Self-Care in Chronic Pain. Clin J Pain 34:818-824
Sturgeon, John A; Ziadni, Maisa S; Trost, Zina et al. (2017) Pain catastrophizing, perceived injustice, and pain intensity impair life satisfaction through differential patterns of physical and psychological disruption. Scand J Pain 17:390-396
Darnall, Beth D; Carr, Daniel B; Schatman, Michael E (2017) Pain Psychology and the Biopsychosocial Model of Pain Treatment: Ethical Imperatives and Social Responsibility. Pain Med 18:1413-1415
Darnall, Beth D; Sturgeon, John A; Cook, Karon F et al. (2017) Development and Validation of a Daily Pain Catastrophizing Scale. J Pain 18:1139-1149
Carriere, Junie S; Martel, Marc-Olivier; Kao, Ming-Chih et al. (2017) Pain behavior mediates the relationship between perceived injustice and opioid prescription for chronic pain: a Collaborative Health Outcomes Information Registry study. J Pain Res 10:557-566

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