A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation Versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain

Chronic low back pain (CLBP) is the most common disabling chronic noncancer pain condition treated with opioids. Many opioid-treated patients experience inadequate pain relief and disability as well as dose-dependent adverse effects of opioids, such as worse mental health, opioid misuse, overdose and death. They frequently have co-occurring depression, anxiety, and opioid use disorders, which worsen outcomes. Poor outcomes and opioid-related harms underscore the need for safe and effective strategies for chronic pain care and opioid dose reduction, especially in high-impact, opioid-treated pain, as noted by the Institute of Medicine, the National Institutes of Health, and the Patient-Centered Outcomes Research Institute.

The investigators pilot randomized controlled trial (RCT) of mindfulness meditation (MM), a popular mind-body modality, demonstrated its potential to safely improve the health of patients and reduce opioid dosage in opioid-treated CLBP. To expand the evidence for MM for use in opioid-treated chronic pain, the investigators propose a 5-year multi-site, mixed-methods pragmatic RCT comparing the effectiveness of MM to standard-of-care cognitive behavioral therapy (CBT) for improving outcomes in opioid-treated CLBP. The study team will follow 766 participants over 12 months and compare outcomes that matter to patients and their families in 383 adults randomized to the MM group to 383 adults randomized to the CBT group, controlling for relevant factors.

The specific aims of this study are:

1. To compare the effectiveness of MM to CBT for reducing pain and increasing function. Current study is based on hypothesis that adults with opioid-treated CLBP in the MM group will report a greater reduction in pain severity and a greater increase in function at 6 and 12 months compared to those in the CBT group.
2. To compare the effectiveness of MM to CBT for improving quality of life (QoL) and reducing daily opioid dose. Study team hypothesize that adults with opioid-treated CLBP in the MM group will report a greater improvement in QoL and a greater decrease in daily opioid dose at 6 and 12 months compared to those in the CBT group.
3. To examine if participant baseline characteristics impact treatment response to MM or CBT. Study team hypothesize that among those with increased baseline symptom severity of anxiety, depression and opioid misuse behaviors, MM will be more beneficial than CBT for improving Aim 1 and Aim 2 outcomes.

Both MM and CBT interventions are patterned after established programs, adapted to meet the needs of patients with opioid-treated CLBP, with input from content experts and patient partners. The manualized interventions are delivered by trained therapists over 8 weeks in weekly two-hour group sessions in addition to care the participants are already receiving from their regular clinicians; during the COVID-19 pandemic, the interventions are delivered virtually. Participants are also be asked to practice MM or CBT strategies at home during the entire study (at least 30 minutes/day, 6 days/week).