Study of a New Cognitive Behavioral Therapy to Treat Persistent Fatigue in Adults with Long-Term Follow-Up in Primary Care

What this Trial Is About

Researchers are investigating fatigue as a common and persistent symptom affecting many primary care patients. This study aims to improve understanding of fatigue and test a new, accessible treatment called transdiagnostic cognitive behavioral therapy tCBT, designed to be used in primary care settings. The study compares tCBT to usual care to see if it can reduce fatigue severity and improve other symptoms over time. It also explores which patient characteristics affect treatment response and includes a long-term follow-up of up to five years. The study involves two groups one receiving tCBT and the other receiving care as usual CAU. The tCBT treatment is delivered in a blended format combining face-to-face therapy sessions with online materials and exercises over 4 to 6 months. CAU includes a variety of treatments typically provided in primary care, such as psychological therapy, physiotherapy, medication, or specialist follow-up. The trial uses random assignment to place participants into one of the two groups. Participants will complete self-rated questionnaires on fatigue and related symptoms, cognitive tests, and physiological monitoring with biometric rings in some cases. Assessments occur regularly during treatment, at 6 months, 12 months, and up to 60 months after starting. Researchers will track fatigue severity changes, cognitive function, mental health symptoms, physical activity, and work ability. The study includes safety monitoring and detailed data collection from healthcare registers to evaluate treatment effects and costs over time.

Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care