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Comparative effectiveness of pain cognitive behavioral therapy and chronic pain self-management within the context of opioid reduction
Investigator (PI): Darnall, Beth
Performing Organization (PO): (Current): Stanford University, School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine / (650) 723-6412
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2024
Record Source/Award ID: PCORI/OPD-1610-37007
Funding: Total Award Amount: $8,808,608
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background and significance: Studies suggest that long term opioid use for chronic pain does not help reduce pain or help patients live fuller lives. Opioid medications have major health risks, even when taken exactly as prescribed, including worsening pain. There are no studies that tell prescribers how to best address their patients' concerns and engage them in opioid reduction, and how to best help them achieve meaningful and successful outcomes that last long term. Our patients told us that for opioid reduction to be successful, the benefit of lower dosage needs to be well understood by them. Further, the patients want to work with their doctors to create together such opioid reduction treatment plan. Based on such input, we developed a patient centered study that encourages patient interest and willingness to actively and collaboratively reduce opioid use and test 2 well established behavioral intervention pain treatment. Study aims: We will test which of the two types of pain management classes described below is best for reducing pain and pain interference, increasing function, and reducing opioids within the context of active, collaborative, patient centered opioid reduction that addresses their main concerns. Study description: We will study the effectiveness of two types of active behavioral pain management treatment classes in patients prescribed long term opioids from primary care and pain clinics in 4 states in the western U.S. Patients who wish to reduce opioids will collaborate with their doctor to co-create a tailored plan to reduce their opioids. Recognizing that some patients are not ready to reduce opioids, we will also enroll patients who decided not to increase their opioid dose during the one-year study period (opioid dose containment group). All study patients will be assigned to either 8-week group cognitive behavioral therapy for chronic pain, 6-week peer led chronic pain self-management program, or no behavioral treatment. Our two active behavioral treatment groups are evidence-based and widely available. We will determine which behavioral treatment works best and for whom for pain control, functioning, and opioid reduction at 12 months within the context of collaborative opioid reduction. We will determine whether the behavioral treatments help improve readiness to reduce opioids for those who elected to hold their opioid dose constant. Our study outcomes were informed by our patient stakeholders and include pain intensity, opioid use, pain interference, role function, anxiety, depression, pain catastrophizing, sleep, fatigue, and medication side effects. Patients with any type of chronic pain may enroll except for such patients with active addiction, behavioral, or safety concerns. Our project focuses on community outpatient settings where most U.S. patients receive prescribed opioids. Our project is designed such that the result can be broadly applied to anywhere in the US.
MeSH Terms:
  • Analgesics, Opioid /*administration & dosage
  • /*adverse effects
  • Anxiety
  • Catastrophization
  • Chronic Pain
  • Cognitive Behavioral Therapy /*methods
  • Community Health Services
  • Comparative Effectiveness Research
  • Depression
  • Fatigue
  • Health Behavior
  • Humans
  • Opioid-Related Disorders /*prevention & control
  • Outcome Assessment, Health Care
  • Outpatients
  • Pain Management /*methods
  • Primary Health Care /organization & administration
  • Self Care
  • Sleep
  • United States
Country: United States
State: California
Zip Code: 94304
UI: 20181665
Project Status: Ongoing
Record History: ('2018: Project start changed from 2017 to 2018 and project end date extended to 2024.',)