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

• Published in: Contemporary clinical trials Vol. 110; p. 106548
• Main Authors: Zgierska, Aleksandra E., Burzinski, Cindy A., Garland, Eric L., Lennon, Robert P., Jamison, Robert, Nakamura, Yoshio, Barrett, Bruce, Sehgal, Nalini, Mirgain, Shilagh A., Singles, Janice M., Cowan, Penney, Woods, David, Edwards, Robert R.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2021
• Subjects: Adult; Analgesics, Opioid - therapeutic use; Chronic low back pain; Chronic pain; Chronic Pain - drug therapy; Cognitive Behavioral Therapy; Humans; Low Back Pain - therapy; Mindfulness; Mindfulness meditation; Mindfulness-based therapy; Opioid therapy; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; RCT; PROs; DSMC; Cognitive behavioral therapy; CLBP; HADS; Chronic pain; QoL; Opioid therapy; COMM; CBT; ODI; Mindfulness meditation; Mindfulness-based therapy; IRB; BPI; Chronic low back pain; MBT
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2021.106548

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. Pragmatic, multi-center randomized controlled trial (RCT). Community and outpatient care. Planned enrollment of 766 adults (383/group) with CLBP treated with long-term opioids (≥3 months; ≥15 mg/day morphine-equivalent dose). 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, 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. 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. •New effective, safe therapies for opioid-treated chronic low back pain are needed.•Mindfulness meditation offers promise but has not been well-studied for this condition.•This trial will compare effectiveness of mindfulness and cognitive behavioral therapy.•The study findings can inform standards of care in opioid-treated chronic pain.