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A comparative effectiveness randomized controlled trial of mindfulness meditation versus cognitive behavioral therapy for opioid-treated chronic low back pain
Investigator (PI): Zgierska, Aleksandra
Performing Organization (PO): (Current): University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health / (608) 263-4550
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/OPD-1601-33860
Funding: Total Award Amount: $8,430,230
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families, and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring nonjudgmental and accepting attention to present-moment experiences, such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping reduce opioid use. Early research, including a pilot study by the principal investigator, indicates that MM has great potential to improve health and well-being of patients with opioid-treated CLBP. However, evidence of MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap. With input from patients, family members, and clinicians, we have designed a study to address this gap. We propose a clinical trial that will compare the effectiveness of MM with CBT in opioid-treated CLBP. Based on the existing research, we hypothesize that MM training will lead to a larger reduction in pain intensity, an increase in physical function, an improvement in quality of life, and a decrease in daily opioid dose, as compared with CBT training. We also hypothesize that the benefits of MM will be especially notable in adults with worse depressed mood, anxiety, or unhealthy opioid-use behaviors; these adults often experience more severe symptoms of CLBP and less improvement in response to existing therapies. To test these hypotheses, we will randomly assign 500 adults in Madison, Wisconsin and Boston, Massachusetts, with opioid-treated CLBP, into one of two eight-week treatment groups: an MM group (n=250) that will receive the MM training or a CBT group (n=250) that will receive the CBT training. We will then compare their outcomes over a 12-month period. We will assess the effectiveness of MM versus CBT with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, who include patients with opioid-treated CLBP, their families, and clinicians. As suggested by our patient partners, we will also conduct interviews with participants to gather additional information about the effects of MM and CBT on pain, function, quality of life, and opioid use. Our partners have helped design this study; they will continue their involvement by helping us finalize the study methods, troubleshoot potential challenges, and advise on dissemination of results so that they can meaningfully inform the decisions that clinicians and patients make about therapy choices.
MeSH Terms:
  • Analgesics, Opioid /*therapeutic use
  • Anxiety /complications
  • Chronic Pain /drug therapy
  • /psychology /*therapy
  • Cognitive Behavioral Therapy
  • Comparative Effectiveness Research
  • Depression /complications
  • Humans
  • Low Back Pain /drug therapy
  • /psychology /*therapy
  • Massachusetts
  • Meditation
  • Mindfulness
  • Opioid-Related Disorders /complications
  • Outcome Assessment (Health Care)
  • Pain Management
  • Pilot Projects
  • Program Evaluation
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Self Care
  • Wisconsin
Country: United States
State: Wisconsin
Zip Code: 53715
UI: 20164149
CTgovId: NCT01775995
Project Status: Ongoing
Record History: ('2018: Start date changed from 2017 to 2018. 2017: Project extended to 2022.',)