NCT04809207

Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF

The CF Wellness Program to Treat Fatigue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.

Detailed description

This study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the CF Wellness Program (CFWP) to treat clinically elevated fatigue in adults with CF. This is a pre-post pilot intervention study of the CF-Wellness Program. This study is needed because fatigue negatively affects health-related quality of life and has been identified by those with CF as a symptom that needs to be addressed. The study will include approximately 50 participants and the intervention will last approximately 13 weeks.

Conditions

• Cystic Fibrosis
• Fatigue

Interventions

Type	Name	Description
OTHER	CF Wellness Program Sessions	The intervention will last approximately 12 weeks. During this time, up to 9 coaching sessions will be delivered. Each will last approximately 45 - 60 minutes. Sessions will be delivered either by web-based video chat (e.g., Zoom) or by telephone. Sessions will cover content such as understanding the physiological, cognitive, affective, behavioral contributors to CF fatigue; understanding the role of physical activity/exercise and fatigue including the importance of balancing activity and rest periods; cognitive restructuring; addressing attention and interpretation processes contributing to fatigue; teaching techniques such as mindfulness meditation relaxation strategies, good sleep hygiene, and activity scheduling and behavioral activation; and engaging social support. Physical activity goals will be set each session. Participants will be encouraged to use the provided fitness tracker and to sync weekly prior the coaching session so that the results can inform session content.

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2021-03-22
• Last updated: 2023-08-28

Locations

2 sites across 1 country: United States