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Table of Contents
In a nutshell
- Both mindfulness-based therapy and cognitive behavioral therapy equally improved pain, function, and quality of life for people with chronic low back pain who were taking opioids.
- Participants in both treatment groups were able to reduce their opioid medication usage over the 12-month study period.
- These psychological approaches can be delivered either in-person or virtually, making them accessible options for chronic pain management.
UNIVERSITY PARK, Pa. — Many people suffering from the constant nagging of back pain often wind up turning to painkillers to bring relief to their frustrating ailment. But new research suggests there might be safer alternatives that can be effective for patients. A clinical trial reveals that two different psychological treatments offer comparable relief for patients using opioid medications for chronic low back pain.
Published in JAMA Network Open, the study followed 770 adults with opioid-treated chronic low back pain for a full year, comparing mindfulness-based therapy (MBT) versus cognitive behavioral therapy (CBT). The researchers found both approaches equally beneficial—contrary to their initial hypothesis that MBT might work better.
The Back Pain Problem and Potential Solutions
Chronic pain affects approximately 50 million American adults, with about 17 million experiencing pain so severe it significantly limits daily activities. Chronic low back pain is the most common type requiring opioid treatment. While opioids help many people, they come with significant risks and often provide inadequate relief, leaving patients searching for additional solutions.
The study, called Strategies to Assist with Management of Pain (STAMP), was led by researchers from the Penn State College of Medicine and the University of Wisconsin-Madiso. They targeted a particularly vulnerable group—people with moderate-to-severe back pain who had been taking opioids for at least three months but still struggled with pain management.
Participants were divided equally between two treatment approaches:
Cognitive behavioral therapy (CBT) focuses on changing unhelpful thought patterns and behaviors. Participants learn to identify negative thoughts about pain and replace them with more constructive ones, while developing practical coping skills.
Mindfulness-based therapy (MBT) teaches awareness and acceptance of present-moment experiences. Rather than trying to eliminate pain, mindfulness helps develop a different relationship with it through techniques like meditation and body awareness exercises.
Both treatments involved eight weekly two-hour group sessions led by experienced therapists, with recommended daily home practice.
Remarkable Results for Both Approaches
Over the 12-month study, both groups showed significant improvements in key measures:
- Pain intensity decreased
- Physical function improved
- Health-related quality of life increased
- Opioid dosage decreased
At the beginning of the trial, the average participant reported moderate pain (scoring 6.1 out of 10), significant functional limitations, reduced quality of life, and high opioid dosages. These weren’t individuals with mild discomfort—they represented patients with complex, persistent pain who had found limited relief from conventional treatments.
The improvements seen in both groups challenge the typical pattern of high-impact chronic pain, which usually worsens over time rather than improves. The fact that participants maintained their improvements throughout the 12-month follow-up suggests these psychological approaches offer lasting benefits.
“In this large trial, chronic low back pain-related symptoms improved, while opioid dosage decreased in both MBT and CBT groups at 6 and 12 months,” the researchers report. “Increasing availability of these safe psychological therapies could help reduce individual and societal burdens of refractory, opioid-treated chronic low back pain.”
What This Means for Back Pain Management
For patients, these findings translate to more treatment options. Since both approaches worked equally well, individuals can choose whichever aligns better with their preferences. Someone who connects with developing mindful awareness might prefer MBT, while those who respond to identifying and changing thought patterns might prefer CBT.
Healthcare providers and insurers should take note as well. Currently, psychological approaches to pain management remain underutilized, partly due to limited access and insurance coverage. This research supports making both MBT and CBT more widely available as treatment options for chronic pain.
The researchers suggest these seemingly different approaches may share core mechanisms despite their distinct philosophies. Both teach self-management skills to regulate thoughts, emotions, and behaviors related to pain.
The results also held true across different delivery methods. When the COVID-19 pandemic forced a shift from in-person to virtual therapy sessions, outcomes remained consistent, suggesting these approaches can be effectively delivered remotely—an important finding for improving accessibility.
For the healthcare system grappling with the ongoing opioid crisis, these findings offer another encouragement. Both treatment groups reduced their opioid dosage over time, suggesting these psychological approaches may help decrease medication dependence while simultaneously improving pain management.
“The study’s findings suggest that both treatments have potential utility in treating adults with refractory chronic low back pain and improving pain, function, and quality-of-life outcomes,” the researchers conclude.
Paper Summary
Methodology
The STAMP trial employed a rigorous methodology to compare these treatments. Researchers recruited participants from primary and specialty care clinics and community settings across three locations: Madison, Wisconsin; Boston, Massachusetts; and Salt Lake City, Utah. Participants had to be English-speaking adults (21 years or older) with chronic low back pain lasting at least three months, taking opioid medication (at least 15 morphine milligram equivalents daily), and experiencing moderate to severe pain intensity and functional limitations.
The study used a partially masked design, meaning that participants and therapists knew which treatment they were receiving (unavoidable given the nature of the interventions), but researchers analyzing the data remained unaware of participants’ group assignments. This helps minimize potential bias in the results.
Participants were randomly assigned to either MBT or CBT using computer-generated permuted blocks of random sizes, stratified by study site to ensure balanced distribution across locations. Both interventions were matched in format and contact time, consisting of 8 weekly 2-hour group sessions led by experienced therapists, along with recommended daily home practice.
The researchers collected outcome measurements at baseline and at 3, 6, 9, and 12 months after treatment initiation. They used validated questionnaires to assess pain severity (Brief Pain Inventory), functional limitations (Oswestry Disability Index), health-related quality of life (SF-12), and daily opioid dose (Timeline Followback).
Results
The results showed significant improvements within both treatment groups compared to their starting points. For the mindfulness group, average pain scores decreased by 0.35 points at 6 months and 0.45 points at 12 months on the 0-10 pain scale. The CBT group showed similar improvements of 0.57 points at 6 months and 0.59 points at 12 months.
Functional limitations also improved in both groups. The mindfulness group showed a 2.15-point improvement at 6 months and 3.19 points at 12 months on the Oswestry Disability Index, while the CBT group improved by 2.24 points at 6 months and 3.49 points at 12 months.
Both groups experienced improvements in health-related quality of life, with the mindfulness group showing a temporary advantage in mental health-related quality of life at 6 months (though this difference disappeared by 12 months).
Perhaps most notably, opioid dosage decreased significantly in both groups over time. The research team found no significant differences between the groups in pain relief, functional improvements, or opioid dose reduction. No serious adverse events were reported in either group.
Limitations
Despite its strengths, the STAMP trial had several limitations worth noting. The researchers acknowledged that without a usual care control group, they couldn’t definitively rule out the possibility that improvements resulted from regression to the mean rather than the treatments themselves. However, they argued that existing research shows high-impact chronic pain typically worsens rather than improves over time, supporting the interpretation that the improvements were treatment-related.
The study sample was predominantly white (81.8%), potentially limiting how well the findings apply to other racial and ethnic groups. Study retention was also lower than anticipated, with outcome data available for 70.4% of participants at 6 months and 65.2% at 12 months—potentially affecting the study’s statistical power to detect between-group differences if they existed.
The COVID-19 pandemic disrupted the study, forcing a shift from in-person to virtual delivery of therapy sessions starting in March 2020. While analysis showed no differences in outcomes based on delivery mode, this represents an unplanned protocol change. Additionally, eligibility criteria were modified during the study to reduce the minimum required opioid dosage from 30 to 15 morphine milligram equivalents per day, reflecting increased opioid tapering practices in the United States.
Funding Information
The STAMP trial was funded through award OPD-1601-33860 from the Patient-Centered Outcomes Research Institute (PCORI) and received additional institutional support from the University of Wisconsin–Madison School of Medicine and Public Health, Brigham and Women’s Hospital at Harvard Medical School, University of Utah College of Social Work, and The Penn State College of Medicine.
Dr. Zgierska reported serving on the board of directors for the American Society of Addiction Medicine, occasionally receiving travel reimbursement. Dr. Garland disclosed serving as Director of UCSD ONEMIND (Optimized Neuroscience-Enhanced Mindfulness Intervention Design), receiving honoraria for delivering mindfulness training seminars, receiving royalties from books related to mindfulness-oriented recovery enhancement, and licensing relationships with BehaVR LLC.
Publication Information
This study, titled “Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial,” was published in JAMA Network Open on April 7, 2025. The authors include Aleksandra E. Zgierska and colleagues from Penn State College of Medicine, Harvard Medical School, University of Wisconsin–Madison, University of Utah, University of California, and other institutions. The study was registered at ClinicalTrials.gov (Identifier: NCT03115359).
