Project Summary

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies 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 the research about?

More than 50 million Americans have chronic pain, or pain that lasts for months or years. Cognitive behavioral therapy, or CBT, is a proven way to treat chronic pain. CBT helps patients learn to change patterns in their thinking to improve how they feel. But most CBT programs have multiple sessions, which makes the programs hard for some patients to complete. A one-session class on pain relief skills may help more people reduce their chronic pain.

In this study, the research team wants to know how well a single class on pain relief skills, called Empowered Relief, reduces chronic pain compared with eight online sessions of CBT.

Who can this research help?

Results may help doctors and patients when considering ways to treat chronic pain.

What is the research team doing?

The research team is recruiting 1,650 adults with chronic pain from six study sites across the United States. The team is assigning patients by chance to receive either Empowered Relief or eight sessions of CBT.

Patients assigned to Empowered Relief receive a two-hour online class on pain management. In the class, a certified instructor teaches ways to reduce pain, such as relaxation techniques and self-soothing.

Patients assigned to CBT complete eight weekly CBT sessions with a trained psychologist. Each session is online and lasts two hours. Sessions address topics such as goal setting, coping skills, and meditation.

At the start of the study and again one, two, three, and six months later, the research team is asking patients to rate their pain. Also, the team is asking patients if their pain gets in the way of doing daily tasks. Finally, the team is comparing how often patients go to the doctor during the three months prior to the study and the last three months of the study.

Patients, health insurers, and professional groups are helping to plan and conduct this study.

Research methods at a glance

Design Element Description
Design

Randomized controlled trial

Population 1,650 adults with an average pain intensity score of at least 3 out of 10
Interventions/
Comparators
  • One 2-hour online session on pain relief skills (Empowered Relief)
  • Eight 2-hour online sessions of CBT
Outcomes

Primary: pain intensity and pain interference

Secondary: sleep disturbance, level of pain bothersomeness, pain catastrophizing, anxiety, satisfaction with social roles/responsibilities, patient global impression of change, depression, fatigue, anger

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 6-month follow-up for study outcomes

*Increase Diversity and Advance Health Equity Funding Supplement
This study received supplemental funding to build on existing PCORI-funded comparative clinical effectiveness research (CER) studies to leverage meaningful engagement of affected/relevant communities to ensure that a diverse and inclusive study population can be achieved.

Project Information

Beth Darnall, PhD
Stanford University
$11,142,765
Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain -- The PROGRESS Study

Key Dates

December 2021
May 2028
2021

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: February 2, 2024