Study of the CF Wellness Program Compared to Usual Care for Adults With Cystic Fibrosis to Improve Fatigue, Sleep, and Physical Activity

What this Trial Is About

Researchers are evaluating the CF Wellness Program CFWP, a behavioral intervention combining cognitive behavioral therapy CBT and physical activity, for adults with cystic fibrosis CF who experience fatigue and poor sleep. The study aims to compare CFWP to usual care in a pilot randomized control trial with 80 participants. The trial focuses on measuring adherence to the intervention, participant retention, and the quality of fitness tracker data. It also seeks to gather preliminary evidence on whether the CFWP improves fatigue, sleep, physical activity, and reduces sedentary behavior compared to usual care. Participants are randomly assigned either to the CFWP group or to usual care. Those in the CFWP group receive written materials and up to eight coaching sessions tailored to fatigue, physical activity, and mental well-being, delivered via web-based video chat or telephone. The sessions last approximately 45 to 60 minutes. The control group continues with their usual clinical care. The follow-up assessment occurs at 15 weeks after baseline. During the study, participants complete assessments at baseline and at week 15, including surveys on fatigue and sleep quality, as well as physical activity measured by fitness trackers and questionnaires. The study collects data on intervention adherence by tracking coaching session attendance and retention by completion of the week 15 assessment. Researchers will also evaluate the quality of daytime and nighttime fitness tracker data. This trial is sponsored by Johns Hopkins University and will run until June 2028.

CF Wellness Program