Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial

Aleksandra E Zgierska; Cindy A Burzinski; Eric L Garland; Robert P Lennon; Robert Jamison; Yoshio Nakamura; Bruce Barrett; Nalini Sehgal; Shilagh A Mirgain; Janice M Singles; Penney Cowan; David Woods; Robert R Edwards

doi:10.1016/j.cct.2021.106548

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial

Contemp Clin Trials. 2021 Nov:110:106548. doi: 10.1016/j.cct.2021.106548. Epub 2021 Sep 1.

Authors

Affiliations

¹ Pennsylvania State University College of Medicine, Departments of Family and Community Medicine, Public Health Sciences and Anesthesiology and Perioperative Medicine, 700 HMC Crescent Road, Hershey, PA 17033, United States of America. Electronic address: azgierska@pennstatehealth.psu.edu.
² University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: cindy.burzinski@fammed.wisc.edu.
³ University of Utah, College of Social Work, 395 1500 E, Salt Lake City, UT 84112, United States of America.
⁴ Pennsylvania State University College of Medicine, Department of Family and Community Medicine and Law School, 700 HMC Crescent Road, Hershey, PA 17033, United States of America. Electronic address: rlennon@pennstatehealth.psu.edu.
⁵ Harvard Medical School, Brigham and Women's Hospital, Departments of Anesthesiology, Perioperative and Pain Medicine and Psychiatry, 850 Boylston Street, Chestnut Hill, MA 02467, United States of America. Electronic address: rjamison@bwh.harvard.edu.
⁶ University of Utah School of Medicine, Department of Anesthesiology, Division of Pain Medicine, Pain Research Center, 615 Arapeen Drive, Suite 200, Salt Lake City, UT 84108, United States of America. Electronic address: yoshi.nakamura@utah.edu.
⁷ University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: bruce.barrett@fammed.wisc.edu.
⁸ University of Wisconsin School of Medicine and Pulic Health, Department of Orthopedics & Rehabilitation, Pain Medicine, 1685 Highland Avenue, Madison, WI 53705-2281, United States of America. Electronic address: sehgal@rehab.wisc.edu.
⁹ University of Wisconsin School of Medicine and Pulic Health, Department of Orthopedics & Rehabilitation, Pain Medicine, 1685 Highland Avenue, Madison, WI 53705-2281, United States of America. Electronic address: smirgain@uwhealth.org.
¹⁰ University of Wisconsin School of Medicine and Pulic Health, Department of Orthopedics & Rehabilitation, Pain Medicine, 1685 Highland Avenue, Madison, WI 53705-2281, United States of America. Electronic address: JSingles@uwhealth.org.
¹¹ American Chronic Pain Association, Inc, PO Box 850, Rocklin, CA 95677, United States of America. Electronic address: pcowan@theacpa.org.
¹² University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: david.woods@fammed.wisc.edu.
¹³ Harvard Medical School, Brigham and Women's Hospital, Departments of Anesthesiology, Perioperative and Pain Medicine and Psychiatry, 850 Boylston Street, Chestnut Hill, MA 02467, United States of America. Electronic address: rredwards@bwh.harvard.edu.

PMID: 34478870
DOI: 10.1016/j.cct.2021.106548

Abstract

Objective: Chronic low back pain (CLBP) is disabling and costly. Existing therapies have proven suboptimal, with many patients resorting to long-term opioid therapy, which can cause harms. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies can be effective and offer unique skills for safe pain coping. This article describes the protocol for a study evaluating comparative effectiveness of CBT and MBT in adults with opioid-treated CLBP.

Design: Pragmatic, multi-center randomized controlled trial (RCT).

Settings: Community and outpatient care.

Participants: Planned enrollment of 766 adults (383/group) with CLBP treated with long-term opioids (≥3 months; ≥15 mg/day morphine-equivalent dose).

Interventions: CBT or MBT consisting of eight weekly therapist-led, two-hour group sessions, and home practice (≥30 min/day, 6 days/week) during the 12-month study.

Main outcome measures: Main outcome measures, collected by self-report at baseline, then three, six, nine and 12 months post-entry, include co-primary measures: pain intensity (Numeric Rating Scale) and function (Oswestry Disability Index), and secondary measures: quality of life (Medical Outcomes Study) and average daily opioid dose (Timeline Followback). Baseline scores of depression, anxiety, and opioid misuse questionnaires will be assessed as potential contributors to the heterogeneity of treatment response. Intention-to-treat, linear mixed-effects analysis will examine treatment effectiveness. Qualitative data will augment the quantitative measures.

Conclusions: This will be the largest RCT comparing CBT and MBT in opioid-treated CLBP. It will provide evidence on the impact of these interventions, informing clinical decisions about optimal therapy for safe, effective care, improving quality of life and decreasing opioid-related harm among adults with refractory CLBP.

Trial registration: ClinicalTrials.gov NCT03115359.

Keywords: Chronic low back pain; Chronic pain; Cognitive behavioral therapy; Mindfulness meditation; Mindfulness-based therapy; Opioid therapy.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Analgesics, Opioid / therapeutic use
Chronic Pain* / drug therapy
Cognitive Behavioral Therapy*
Humans
Low Back Pain* / therapy
Mindfulness*
Pragmatic Clinical Trials as Topic
Randomized Controlled Trials as Topic

Substances

Analgesics, Opioid

Associated data

ClinicalTrials.gov/NCT03115359