A year-long clinical trial showed that both mindfulness-based therapy and cognitive behavioral therapy significantly reduce pain and opioid use in adults with chronic low back pain, with comparable long-term outcomes.
Study: Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial. Image Credit: Sasin Paraska / Shutterstock.com
Both mindfulness-based therapy (MBT) and standard-of-care cognitive behavioral therapy (CBT) have been used to for the treatment of adults with refractory chronic low back pain (CLBP). A recent JAMA Network Open study compares the long-term effectiveness of MBT and CBT among adults with opioid-treated CLBP.
Current treatments for chronic low back pain
Chronic non-cancer pain affects over 50 million adults in the United States and, as a result, is one of the leading causes of disability and reduced quality of life (QOL). CLBP is also one of the most common types of chronic non-cancer pain that is treated with opioids.
In addition to the numerous adverse effects associated with long-term opioid use, this treatment is often unable to alleviate CLBP, thus emphasizing the crucial need for new interventions. Although the effectiveness of psychologically oriented treatments for CLBP has been documented, restricted access and insurance coverage limits the widespread use of these therapies.
CBT is an active self-management training that helps patient cope with their condition based on adaptive changes in their behavior and cognition. For chronic pain, CBT is considered a standard psychological treatment that is associated with marginal benefits in alleviating pain in patients with CLBP.
Mindfulness-based therapy (MBT) is another psychological treatment that provides patients with skills to accept their chronic pain. These patients are encouraged to cultivate non-judgmental and nonreactive meta-awareness of present-moment experiences.
To date, no studies have compared the long-term effectiveness of MBT and CBT, particularly for opioid-treated CLBP patients.
About the study
The Strategies to Assist with Management of Pain (STAMP) is a two-arm, multisite, and randomized clinical trial (RCT) comparing the effects of the MBT and CBT alongside standard care among opioid-treated CLBP adults.
The researchers of the current study hypothesized that, considering the analgesic mechanisms of mindfulness, MBT would be more effective than CBT in improving pain, function, and QOL of patients experiencing CLBP. MBT was also predicted to reduce opioid dosage six- and 12 months after initiating therapy.
Study participants 21 years and older were enrolled between July 1, 2017, and August 4, 2021. All study participants experienced daily pain in the lumbosacral region or sciatica and were treated with 15 or more morphine milligram equivalents (MME) every day for at least three months.
The average daily pain intensity on the Brief Pain Inventory (BPI) was at least three. Individuals with a history of MBT and/or CBT, psychiatric disorders, or pregnancy were excluded from the analysis.
Study participants were randomly assigned into MBT and CBT groups in a 1:1 ratio. All interventions were personalized to the needs of each individual.
Both study cohorts completed a total of eight weekly two-hour therapist-led group sessions. All patients were encouraged to practice the recommendations for at least 30 minutes every day for six days/week during the duration of the study.
MBT group participants were encouraged to adapt to mindfulness before deciding whether they require opioid medication, as this mindful pause may disrupt automaticity and reduce opioid use. In contrast, participants in the CBT group were provided with a variety of cognitive-behavioral strategies that could aid in active self-management.
The outcome measures were collected at baseline and three, six, nine, and 12 months after treatment initiation. The impact of MBT as compared to CBT was assessed using a linear mixed-effects model (LMEM) at six and 12 months.
Real-world benefits after one year
Approximately 70% and 65% of study participants provided primary outcome data at six and 12 months, respectively. The rates of session attendance, loss-to-follow-up, and weekly minutes of home practice were not significantly different between both study groups.
A total of 385 participants were included in both the MBT and CBT groups, 56.4% of whom were female and 42.6% male. The mean age of the study participants was 57.8 years, most of whom were non-Hispanic or non-Latino ethnicity.
At baseline, study participants of both groups reported moderate functional limitations, average health-related QOL, mean pain scores of 6.1 on the BPI scale, and high mean opioid dosages.
As compared to baseline, both study groups reported significant improvements in primary and secondary outcomes at six and 12 months. In the MBT group, the change in BPI score for average pain from baseline was -0.35 and -0.45 at six and 12 months, respectively.
In the CBT group, the change in pain from baseline was -0.57 and -0.59 at six and 12 months, respectively. Similar changes in scores for functional limitations in both groups were also recorded.
The linear mixed-effects model analysis did not identify a significant change between the study groups in primary and secondary outcomes at six and 12 months. Likewise, no between-group differences were observed over time in pain interference or percentage of individuals treated with high MME dosages.
However, as compared to CBT, a greater improvement in mental health-related QOL was observed in the MBT group at six months.
Conclusions
Both MBT and CBT led to significant and comparable improvements in CLBP intensity and reductions in opioid dose that persisted for up to 12 months following the initial intervention without any serious adverse effects. These findings support incorporating both MBT and CBT into the treatment of patients with CLBP.
Journal reference:
- Zgierska, A. E., Edwards, R. R., Barrett, B., et al. (2025) Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial. JAMA Network Open 8(4):e253204. doi:10.1001/jamanetworkopen.2025.3204