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Randomized Controlled Trial
. 2025 Apr 1;8(4):e253204.
doi: 10.1001/jamanetworkopen.2025.3204.

Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial

Aleksandra E Zgierska  1   2   3 , Robert R Edwards  4   5 , Bruce Barrett  6 , Cindy A Burzinski  6 , Robert N Jamison  4   5 , Yoshio Nakamura  7 , Mary F Henningfield  6 , Wen-Jan Tuan  1 , Chan Shen  2   8 , Nalini Sehgal  9 , Robert P Lennon  1 , Huamei Dong  2 , Vernon M Chinchilli  2 , Yuxin Liu  2 , Alyssa Turnquist  6 , Anthony R Schiefelbein  10 , Elizabeth A Jacobs  11 , Christin Veasley  12 , Penney Cowan  13 , Eric L Garland  14   15
Affiliations
Randomized Controlled Trial

Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial

Aleksandra E Zgierska et al. JAMA Netw Open. .

Abstract

Importance: Chronic low back pain (CLBP) can necessitate opioid therapy. Effective approaches to reduce CLBP's symptoms and opioid-related harms are needed. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies may be useful but have not been well-studied for opioid-treated CLBP.

Objective: To compare the effectiveness of MBT vs CBT in opioid-treated CLBP, hypothesizing MBT's superiority.

Design, setting, and participants: In this 12-month community partner-informed, partially masked, multisite, randomized clinical trial, participants at primary and specialty care clinics and community settings were randomly assigned (1:1) to MBT or CBT groups. Participants included English-fluent adults (21 years or older), without prior MBT or CBT training, and with moderate-to-severe CLBP (average score ≥3 on the Brief Pain Inventory [BPI]; functional limitation score ≥20 on the Oswestry Disability Index [ODI]), treated with an opioid dosage of at least 15 mg/d of morphine milligram equivalents (MME) for at least 3 months. Outcome data were collected from July 1, 2017, to November 23, 2022. Analysis used the intention-to-treat approach.

Interventions: Manual-based MBT or CBT interventions consisting of 8 weekly therapist-led group sessions and at-home practice.

Outcomes and measures: Self-reported coprimary (average pain severity, 0-10 [BPI]; functional limitations, 0-100 [ODI]) and secondary (mental and physical health-related quality of life [QOL] on the Medical Outcomes Study 12-Item Short Form Health Survey and opioid dose in MME per day, Timeline Followback) outcomes compared at 6 and 12 months.

Results: Among 6024 screened individuals, 2926 were ineligible, 2328 were eligible, and 770 were enrolled, including 385 in the MBT and 385 in the CBT groups. Of these, 434 participants (56.4%) were female, 647 (84.0%) identified as non-Hispanic ethnicity, and 630 (81.8%) identified as White race; mean (SD) age was 57.8 (11.3) years. The mean (SD) BPI average pain score was 6.1 (1.6) (moderate pain) and the mean (SD) ODI functional limitation score was 47.2 (14.0) (moderate functional limitations), with reduced physical (mean [SD], 28.5 [8.3]) and mental (mean [SD], 42.5 [11.8]) health-related QOL on the SF-12 and high opioid dosage (mean [SD], 177 [1041] MME/d). Over time, each group significantly improved their outcomes, without serious adverse effects. The intention-to-treat linear mixed-effects model analysis did not detect significant between-group differences at 6 and 12 months for pain (0.21 [95% CI, -0.05 to 0.48; P = .12] and 0.13 [95% CI, -0.13 to 0.40; P = .33], respectively) or function (0.07 [95% CI, -1.80 to 1.93; P = .94], and 0.27 [95% CI, -1.59 to 2.12; P = .78], respectively) and indicated MBT's noninferiority relative to CBT on primary outcomes.

Conclusions and relevance: In this large trial, CLBP-related symptoms improved, while opioid dosage decreased in both MBT and CBT groups at 6 and 12 months. Increasing availability of these safe psychological therapies could help reduce individual and societal burdens of refractory, opioid-treated CLBP.

Trial registration: ClinicalTrials.gov Identifier: NCT03115359.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Zgierska reported serving on the board of directors and executive committee for the American Society of Addiction Medicine and receiving reimbursement of some of the travel cost 1 to 2 times per year to in-person meetings of this society outside the submitted work. Dr Garland reported serving as the Director of UCSD ONEMIND (Optimized Neuroscience-Enhanced Mindfulness Intervention Design), which provides mindfulness-oriented recovery enhancement (MORE), mindfulness-based therapy, and cognitive behavioral therapy in the context of research trials for no cost to research participants; receiving honoraria and payment for delivering seminars, lectures, and teaching engagements (related to training clinicians in mindfulness), including those sponsored by institutions of higher education, government agencies, academic teaching hospitals, and medical centers; receiving royalties from the sale of books related to MORE; and being a licensor to BehaVR LLC. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. The Strategies to Assist With Management of Pain Study Participant Flow
CBT indicates cognitive behavioral therapy; ITT, intention to treat; and MBT, mindfulness-based therapy.
Figure 2.
Figure 2.. Primary Outcomes by Group Status Over Time
A, Average pain score is measured by a single item on the Brief Pain Inventory (BPI; range, 0-10, with higher scores indicating greater severity of average pain). B, Functional limitations are measured using the Oswestry Disability Index (ODI; range, 0-100, with higher scores indicating greater limitations). Significant reductions in values were noted within each group, compared with baseline; however, no statistically significant differences in score change were found between the groups over time. Scores are presented as estimated marginal means and SEs. CBT indicates cognitive behavioral therapy group; MBT, mindfulness-based therapy group. Details on the estimated marginal means and SEs at each follow-up point are included in eTable 4 in Supplement 2.
See this image and copyright information in PMC

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