Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain

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.

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Work Title Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain
Subtitle Protocol for a pragmatic randomized controlled trial
Access
Open Access
Creators
  1. Aleksandra E. Zgierska
  2. Cindy A. Burzinski
  3. Eric L. Garland
  4. Robert P. Lennon
  5. Robert Jamison
  6. Yoshio Nakamura
  7. Bruce Barrett
  8. Nalini Sehgal
  9. Shilagh A. Mirgain
  10. Janice M. Singles
  11. Penney Cowan
  12. David Woods
  13. Robert R. Edwards
License In Copyright (Rights Reserved)
Work Type Article
Publisher
  1. Contemporary Clinical Trials
Publication Date November 1, 2021
Publisher Identifier (DOI)
  1. https://doi.org/10.1016/j.cct.2021.106548
Deposited November 16, 2021

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Version 1
published

  • Created
  • Added mindfulness.opioid.pdf
  • Added Creator Aleksandra E. Zgierska
  • Added Creator Cindy A. Burzinski
  • Added Creator Eric L. Garland
  • Added Creator Robert P. Lennon
  • Added Creator Robert Jamison
  • Added Creator Yoshio Nakamura
  • Added Creator Bruce Barrett
  • Added Creator Nalini Sehgal
  • Added Creator Shilagh A. Mirgain
  • Added Creator Janice M. Singles
  • Added Creator Penney Cowan
  • Added Creator David Woods
  • Added Creator Robert R. Edwards
  • Published
  • Updated
  • Updated
  • Updated