TY - JOUR
T1 - Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain
T2 - Protocol for a pragmatic randomized controlled trial
AU - Zgierska, Aleksandra E.
AU - Burzinski, Cindy A.
AU - Garland, Eric L.
AU - Lennon, Robert P.
AU - Jamison, Robert
AU - Nakamura, Yoshio
AU - Barrett, Bruce
AU - Sehgal, Nalini
AU - Mirgain, Shilagh A.
AU - Singles, Janice M.
AU - Cowan, Penney
AU - Woods, David
AU - Edwards, Robert R.
N1 - Funding Information:
The reported work was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award ( OPD-1601-33860 ). The views and statements in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors or Methodology Committee. This project also received funding and institutional support through University of Wisconsin-Madison School of Medicine and Public Health , and its Department of Family Medicine and Community Health ; Brigham and Women's Hospital, Harvard Medical School ; University of Utah College of Social Work ; and Pennsylvania State University Department of Family and Community Medicine .
Funding Information:
The reported work was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (OPD-1601-33860). The views and statements in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors or Methodology Committee. This project also received funding and institutional support through University of Wisconsin-Madison School of Medicine and Public Health, and its Department of Family Medicine and Community Health; Brigham and Women's Hospital, Harvard Medical School; University of Utah College of Social Work; and Pennsylvania State University Department of Family and Community Medicine.
Funding Information:
We would like to thank the University of Wisconsin-Madison (UW), UW Institute for Clinical and Translational Research, supported by the Clinical and Translational Science Award and the National Center for Advancing Translational Sciences (1UL1TR002373), Brigham and Women's Hospital, University of Utah, Pennsylvania State University, the American Chronic Pain Association, Inc., the Chronic Pain Research Alliance, and the UW's Wisconsin Network for Research Support for their support in the development of this study protocol.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85114680142&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85114680142&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2021.106548
DO - 10.1016/j.cct.2021.106548
M3 - Article
C2 - 34478870
AN - SCOPUS:85114680142
VL - 110
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 106548
ER -