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
Randomized controlled trial
|1,650 adults with an average pain intensity score of at least 3 out of 10
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
|6-month follow-up for study outcomes
*Increase Diversity and Advance Health Equity Funding Supplement
Study Registration Information
- Allergies and Immune Disorders
- Immune Disorders
- Multiple/Comorbid Chronic Conditions
- Muscular and Skeletal Disorders
- Chronic Back Pain
- Nutritional and Metabolic Disorders
- Neurological Disorders
- Chronic Pain
- Blood Disorders
- Sickle Cell Disease
- Reproductive and Perinatal Health