Research Summary

Mindfulness vs Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain: 12-Month Randomized Trial Results

Edited by:
Ashton L. Stahl

  Key Highlights

  • In a 770-patient randomized trial, mindfulness-based therapy and cognitive behavioral therapy produced comparable improvements in pain and function at 6 and 12 months.
  • Both groups experienced significant reductions in average pain severity and functional limitations.
  • Daily opioid dose decreased significantly in both groups over 12 months.
  • No serious adverse events were reported.

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In a 12-month, multisite randomized clinical trial published in JAMA Network Open, mindfulness-based therapy (MBT) was not superior to cognitive behavioral therapy (CBT) for adults with opioid-treated chronic low back pain (CLBP). Still, both interventions were associated with sustained improvements in pain, function, quality of life, and opioid dose reduction.

The Strategies to Assist With Management of Pain (STAMP) trial enrolled 770 adults aged 21 years or older with moderate-to-severe CLBP treated with at least 15 morphine milligram equivalents (MME) per day for at least 3 months. Participants were randomized 1:1 to MBT or CBT, each delivered as 8 weekly 2-hour therapist-led group sessions with recommended home practice. Coprimary outcomes were average pain severity on the Brief Pain Inventory (BPI; 0–10 scale) and functional limitations on the Oswestry Disability Index (ODI; 0–100 scale), assessed at 6 and 12 months using an intention-to-treat approach. Secondary outcomes included mental and physical health–related quality of life (SF-12) and daily opioid dose measured by Timeline Followback.

Study Findings

At baseline, participants reported moderate pain (mean BPI 6.1) and functional limitation (mean ODI 47.2), reduced physical and mental quality of life, and high mean opioid doses (177 MME/day). Over 12 months, both MBT and CBT groups demonstrated statistically significant within-group improvements in pain and function.

In the MBT group, mean BPI scores decreased by −0.35 (95% CI, −0.54 to −0.17) at 6 months and −0.45 (95% CI, −0.64 to −0.26) at 12 months (P < .001 for both). In the CBT group, BPI scores decreased by −0.57 (95% CI, −0.76 to −0.38) at 6 months and −0.59 (95% CI, −0.78 to −0.40) at 12 months (P < .001 for both). ODI scores improved by −2.15 at 6 months and −3.19 at 12 months in the MBT group and by −2.24 and −3.49, respectively, in the CBT group.

Between-group analyses using linear mixed-effects models showed no statistically significant differences in changes in pain or function at either time point. At 6 months, the between-group estimate for BPI change was 0.21 (95% CI, −0.05 to 0.48; P = .12), and, at 12 months, it was 0.13 (95% CI, −0.13 to 0.40; P = .33). Functional outcomes similarly showed no significant differences. Post hoc noninferiority analyses indicated that MBT was noninferior to CBT for the coprimary outcomes.

Both groups also experienced significant reductions in log-transformed daily MME at 6 and 12 months (P < .001 within groups), without significant between-group differences. No serious adverse events were reported.

Clinical Implications

According to the study authors, the findings suggest that both MBT therapy and CBT may provide durable benefits for adults with refractory, opioid-treated CLBP. The authors note that MBT, like CBT, should be considered a treatment option to integrate into standard care and that increasing availability of these psychological therapies could help reduce the burden of chronic low back pain and opioid-related harms.

This study had limitations. For example, the trial lacked a usual care control group, raising the possibility of regression to the mean. The study also experienced lower-than-anticipated enrollment and retention, particularly among diverse racial and ethnic groups, potentially limiting power to detect between-group differences.

Expert Commentary

“In this largest, to our knowledge, RCT of MBT vs CBT for opioid-treated chronic pain to date, both MBT and CBT groups experienced significant, comparable improvements in CLBP and reductions in opioid dose, sustained through 12 months, without serious adverse effects. MBT, like CBT, should be considered a treatment option to integrate into standard-of-care for complex, refractory, opioid-treated CLBP,” the researchers concluded.

Reference

Zgierska AE, Edwards RR, Barrett B, et al. Mindfulness vs cognitive behavioral therapy for chronic low back pain treated with opioids: a randomized clinical trial. JAMA Netw Open. 2025;8(4):e253204. doi:10.1001/jamanetworkopen.2025.320