Project Summary

PCORI has identified opioid use for chronic pain as an important research topic. Patients, clinicians, and others want to learn: How can patients lower their use of opioid medications while managing chronic pain, or eliminate use of these drugs altogether? To help answer this question, PCORI launched an initiative in 2016 on Clinical Strategies for Managing and Reducing Long Term Opioid Use for Chronic Pain. The initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is this research about?

Chronic pain is pain that lasts for several months or longer. More than 116 million Americans live with some degree of chronic pain. Opioid medicines can help people control some short-term pain when taken as prescribed. But it is not clear if opioids are safe and effective for chronic pain. Cognitive behavioral therapy, or CBT, is one type of treatment for chronic pain, and may help people reduce opioid use. With CBT, patients learn to change their patterns of thinking and behaving.

In this study, the research team is comparing three types of treatment for people who have chronic pain and who are working with a clinician, such as a doctor or nurse practitioner, to actively reduce their opioid use. The treatments are psychologist-led group CBT for chronic pain, peer-led group sessions on self-managing chronic pain, and usual care focusing on dose reduction, to see how each treatment affects patients’ opioid use, their levels of pain, and how they feel.

Who can this research help?

Pain clinics and clinicians who treat chronic pain can use findings from this study to decide how best to support patients in reducing use of opioids to manage chronic pain. 

What is the research team doing?

The team is recruiting 865 patients ages 18 to 85 with chronic pain at health clinics in four states in the western United States. Patients must have had chronic pain for at least six months and have been taking opioids for at least three months. The study does not include patients with chronic pain from cancer or who have an addiction to opioids.

All patients in the study are creating a plan with their doctor to slowly reduce their opioid use. The research team is assigning patients by chance to one of three groups.

  • Psychologist-led group CBT for chronic pain. Patients take part in eight two-hour support group meetings led by psychologists. Sessions focus on relaxation, how to manage pain, home exercises, and other topics.
  • Peer-led group sessions on self-managing chronic pain. Patients take part in a support group led by two certified peers for six two-hour sessions. The peers are people with chronic pain trained in a self-management program to help other people with chronic pain. This group uses a workbook with many of the same activities as the psychologist-led group.
  • Usual care. Patients in this group are creating an opioid reduction plan with their doctor, but not taking part in a support group.

The team is comparing patients’ pain levels and opioid use at the start of the study and one year later.

Patients with chronic pain are providing input on the study. Patients, family members, patient advocacy groups, and national pain organizations are also helping design products and community trainings. The products and trainings will be free and publicly available at the end of the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 865 adults ages 18 to 85 who have had chronic non-cancer pain for at least 6 months and who have been taking opioids for at least 3 months 
Interventions/
Comparators
  • Therapist-led group CBT for chronic pain
  • Peer-led group sessions on self-managing chronic pain
  • Usual care 
Outcomes

Primary: opioid use, pain levels

Secondary: opioid side effects, experience of how pain affects life activities, function, anxiety, depression, thoughts and feelings of helplessness about pain, sleep, tiredness

Timeframe 12-month follow-up for primary outcomes

More to Explore...

Videos

Research on How to Reduce the Use of Opioids
Beth Darnall of Stanford University School of Medicine shares how her PCORI-funded project, The EMPOWER Study, aims to help find the best way to empower patients with chronic pain to reduce their use of opioids and better manage their pain.

Opinion Column

Addressing the dual crises of pain and opioids — a case for patient-centeredness
In an opinion piece, Darnall writes that addressing pain "has become deeply intertwined with the opioid crisis" so pain treatment programs need to be evidence based and patient centered. (The Hill, 10/31/2018)

Project Information

Beth Darnall, PhD
Stanford University School of Medicine
$8,808,608
Comparative Effectiveness of Pain Cognitive Behavioral Therapy and Chronic Pain Self-Management within the Context of Opioid Reduction -- The EMPOWER Study

Key Dates

September 2017
March 2024
2017

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022