One of the biggest health problems in the United States is chronic pain, impacting more Americans than diabetes, cancer, and heart disease combined. Women, older adults, racial minorities, and people of lower incomes are impacted more by chronic pain and have the greatest barriers to pain care. An important part of treating chronic pain involves teaching people what they can do in their daily lives to help lessen their pain and its impacts. The current gold standard of this type of “behavioral” treatment for pain is cognitive behavioral therapy (CBT) delivered by a trained therapist. Many people cannot access CBT due to time (eight sessions, 16 hours total) or travel burdens. Moreover, not all patients need eight sessions to learn pain relief skills. Indeed, a single-session two-hour pain relief skills class called “Empowered Relief” (ER) helped people as much as eight-session CBT in initial studies. In addition, online delivery has the potential to increase accessibility to pain care. Therefore, this study will compare online ER to online CBT in 1,200 adults with a variety of medical and pain conditions, living in different parts of the United States, and with different income levels, who are receiving their medical care or coverage at one of six study sites.
This study will include those most commonly overlooked in health research, including older adults with Medicare/Medicaid (often lower income), racial/ethnic minorities, and people living in rural areas. The project team will help people of lower incomes join the study by providing iPads when needed and will accommodate those with low computer skills or no access to internet. In addition, when designing the study, the team included patients’ perspectives through surveys of about 2,000 patients. The team selected study outcomes that mattered the most to patients. The study team includes five payers, eight national professional organizations, an Engagement Chair, a Patient Engagement and Diversity Board, and National Patient Advisory Panel, assuring patient-centeredness and broad dissemination and adoption of study findings.
Participants will be randomly assigned to receive either online eight-session CBT or online one-session ER. Both treatments are low/no risk. Measures will include results from seven electronic surveys (post-treatment months 1-3 and 6), data from electronic health records or insurance records diagnoses (medical, pain, and mental health), prescriptions, and number of health service visits received over two three-month periods. The team designed the study to accomplish the following aims:
Aim 1: Compare online treatment groups for pain intensity and pain interference at three months post-treatment. The team expects that ER will be comparable to eight-session CBT for improving these outcomes.
Aim 2: Compare online treatment groups for sleep disturbance, pain catastrophizing score, pain bothersomeness, anxiety, treatment completion, and treatment burden. The team expects that ER will be comparable to eight-session CBT for improving these outcomes and that ER will have better treatment completion and lower treatment burden ratings.
Aim 3: Compare online treatment groups for satisfaction with social roles and responsibilities, patient global impression of change, anger, fatigue, and depression. The team expects that ER will be comparable to eight-session CBT for improving these outcomes.
Aim 4: Compare treatment effects at six months post-treatment. The team expects that ER will be comparable to eight-session CBT for all outcomes at six months, with both treatments showing lasting effects.
Exploratory Aim 5: Compare number of healthcare visits for the three months prior to enrollment to the last three months of the study period. The team expects that both treatment groups will show fewer healthcare visits during the final three study months.
Exploratory Aim 6: Allow ER participants who had less than a 20 percent improvement on either primary outcome to switch to online eight-week CBT at six months. The team expects that eight-session CBT will help people who were not helped by ER.
For all outcomes, the team will examine whether treatment response differs by sex/gender, pain type, number of chronic pain conditions, race/ethnicity, income level, disability status, and Medicare/Medicaid status.
Results from the study will inform shared decision making, provide information on pain treatment “dosing” (one versus eight sessions), and help match patients to the best treatment while reducing treatment burden and out-of-pocket costs. Results will help patients of lower income who often have limited treatment options. As the study includes a large number of Medicare/Medicaid patients, results are expected to inform national policy.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.