Rebecca Shelby, PhD, and Tamara Somers, PhD, of the Department of Psychiatry & Behavioral Sciences at the Duke University School of Medicine will lead the clinical coordinating center for a $13 million, five-year study funded by the Patient-Centered Outcomes Research Institute (PCORI). The study will aim to improve symptom management and quality of life for adults living with rare cholestatic liver diseases.
The study, TRANSFORM-EMPOWER, is led by principal investigator Donna Evon, PhD, professor of medicine in the Division of Gastroenterology and Hepatology at the UNC School of Medicine, with co-principal investigator Puneeta Tandon, MD, professor of medicine at the University of Alberta.
The research team will enroll approximately 600 adults with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) at 17 liver centers across the United States and Canada. The Duke clinical coordinating center will work closely with investigators at UNC, the University of Alberta, participating liver centers, and patient advocacy organizations throughout the project.
The study will compare a digital mind-body symptom management program used alone with the same digital program combined with clinician-guided virtual group psychotherapy. Researchers will evaluate the effects of these approaches on mental health, fatigue, and other symptoms that can substantially affect quality of life for people living with these chronic diseases.
“TRANSFORM-EMPOWER provides an exciting opportunity to bring behavioral medicine and clinical research expertise to an important unmet need for people living with rare liver diseases. We are particularly excited about the study’s focus on both effectiveness and implementation — understanding not only whether these interventions work, but how they can be integrated into routine clinical care.”
— Rebecca Shelby, PhD, professor in psychiatry and behavioral sciences
As leaders of the clinical coordinating center, Shelby and Somers will provide centralized scientific coordination across the participating clinical sites. Duke Psychiatry & Behavioral Sciences faculty involved in the clinical coordinating center include associate professor Caroline Dorfman, PhD, and associate professor Catherine Majestic, PhD.
The Duke clinical coordinating center team will support consistent implementation of the study interventions, facilitate collaboration among investigators and clinical teams, and coordinate activities across the large international clinical research network. Duke University School of Medicine faculty involved in the TRANSFORM-EMPOWER study include Julius Wilder, MD, associate professor of medicine, Bryce Reeve, PhD, and Keith Marsolo, PhD, both professors in population health sciences.
The study was developed in close collaboration with PBC and PSC patient advocacy organizations and will establish hepatologist-psychologist teams at participating centers. This approach is designed to address the limited access many patients have to behavioral health providers who understand the challenges of living with rare and chronic liver diseases.
“People with rare chronic diseases often experience significant symptom burden while facing substantial barriers to behavioral healthcare. This study has the potential to provide a scalable model for integrating behavioral health into specialty medical care, while also generating evidence that could inform care for people with other chronic and rare conditions.”
— Tamara Somers, PhD, professor in psychiatry and behavioral sciences
In addition to evaluating the comparative effectiveness of the two approaches, TRANSFORM-EMPOWER will examine how the interventions can be integrated and sustained in real-world clinical practice. The study’s findings could inform new models for delivering accessible behavioral health and symptom management services to patients with chronic disease.
The funding award to The University of North Carolina at Chapel Hill has been approved pending completion of PCORI’s business and programmatic review and issuance of a formal award contract. PCORI is a nonprofit organization with a mission to fund patient-centered CER designed to provide patients and those who care for them with evidence to make better-informed healthcare decisions.