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

Summary

In a multisite RCT (n=770) of opioid-treated chronic low back pain, both mindfulness-based therapy and cognitive behavioral therapy significantly improved pain and function over 6 and 12 months, with no serious adverse events. MBT was noninferior to CBT on primary outcomes, and opioid dosage decreased in both groups.

Key Findings

• 770 participants randomized (385 per group); both MBT and CBT significantly improved BPI pain and ODI function at 6 and 12 months.
• No significant between-group differences; MBT demonstrated noninferiority to CBT on primary outcomes.
• Opioid dosage decreased over time in both groups without serious adverse events.

Clinical Implications

Clinicians can offer MBT or CBT to opioid-treated CLBP patients, expecting similar improvements in pain and function and reductions in opioid dose. Expanding access to either therapy could mitigate opioid-related harms.

Limitations

• Partial masking may introduce expectation effects; adherence and practice intensity may vary.
• Sample was predominantly White and English-fluent, which may limit generalizability.

Future Directions

Assess cost-effectiveness, digital delivery formats, and effectiveness in more diverse populations and usual-care comparators; explore moderators/mediators of response.