CF Wellness Program

Not Applicable

Not yet recruiting

• Conditions: Cystic Fibrosis (CF); Fatigue; Sleep Quality; Insomnia

• Registration Number: NCT07071324
• Lead Sponsor: Johns Hopkins University

Brief Summary

This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study Retention (completion of the Week 15 assessment) and (3) Data Quality (valid daytime and nighttime fitness tracker data). A secondary aim is to gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and physical activity (PA) and reduce sedentary behavior.

Detailed Description

Highly effective modulator therapy (HEMT) has improved lung health for many adults with cystic fibrosis (CF), but does not appear to have translated into improved fatigue, sleep, or physical activity (PA). A study of 236 adults with CF (86% of whom were taking HEMT) found that 43% experienced elevated fatigue, while 63% reported poor sleep quality. Fatigue, poor sleep, and less PA are associated with worse physical and mental health outcomes, such as respiratory symptoms, lung function, depression, and anxiety. Cognitive behavioral therapy (CBT) is a well-established treatment for insomnia, pain, and mood disorders, with emerging data that it helps with fatigue. Similarly, increasing PA reduces fatigue and improves sleep. There is no research evaluating whether CBT or PA improves fatigue or sleep for adults with CF. Investigators developed a CBT+PA intervention for adults with CF and fatigue, known as the CF Wellness Program (CFWP), which includes written materials and up to eight virtual sessions with a Coach. The goal of the proposed pilot study is twofold. First, to evaluate session attendance and determine if research-quality fitness tracker data can be collected to objectively measure sleep and PA. Second, investigators will gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and PA and reduce sedentary behavior. This study will enroll 80 adults with CF and fatigue. After completing the baseline assessment, half the participants will be randomized to receive the CFWP and half will not. The follow-up assessment will be collected at Week 15.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-09-15
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. ≥18 years old
2. Documentation of CF diagnosis in the medical record
3. Score of >4 on the Fatigue Severity Scale
4. Access to a smartphone, tablet, and/or computer with access to internet
5. Ability to understand/read/speak English
6. Receives CF care at a participating CF Center

Exclusion Criteria

1. Pulmonary exacerbation (physician determined and may include oral antibiotics, IV antibiotics, hospitalization) ±14 days of enrollment
2. Pregnant or <6 months post-partum (self-reported)
3. Contraindication to light physical activity (as determined by the treating physician and may include pulmonary, cardiovascular, or musculoskeletal contraindications)
4. Participated in the CFWP Feasibility Study
5. Currently enrolled in another interventional trial
6. Unavailable to complete coaching sessions within the study timeframe

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention Adherence as assessed by the number of CFWP participants	Up to 15 weeks	The number of participants randomized to receive the CFWP who complete all 8 coaching sessions.
Participant Retention as assessed by the number of participants completing the week 15 assessment survey	Week 15	The number of participants across both study groups who complete the week 15 assessment survey.
Fitness Tracker Data Quality as assessed by the number of participants who have valid activity and sleep data.	Baseline, Week 15	The number of participants who have valid sleep and activity data at the baseline and week 15 assessment. Valid physical and sleep activity was defined as \>10 hours of collected data across 4 days, including 1 weekend day and overnight.

Secondary Outcome Measures

Name	Time	Method
Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F)	Baseline, Week 15	The number of CFWP participants reporting clinically improved fatigue compared to UC participants at the week 15 assessment. The FACIT-F is a 14-question instrument used to assess self-reported fatigue. Scores range from 0-52, with a score of \<34 indicating clinically significant fatigue. Lower scores indicate higher fatigue. Clinically improved fatigue is defined as a ≥4 points increase in the FACIT-F or no longer having fatigue (FACIT-F ≥34).
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)	Baseline, 15 weeks	The PSQI is a 19-item questionnaire that measures an individual's quality of sleep over the last month. Scores range from 0 to 21, with a score \>5 indicative of poor sleep quality.
Sleep Quality as assessed by the Insomnia Severity Index (ISI)	Baseline, 15 weeks	The ISI is a 7-item scale measuring the impact of insomnia in the past month. Total score ranging from 0 to 28, scores are categorized to indicate the severity of insomnia, ranging from no clinically significant insomnia (0-7) to severe insomnia (22-28). Higher score more severe insomnia.
Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C).	Baseline, 15 weeks	The CSD-C is a 9-item self-reported diary of sleep activity to determine patterns such as good sleeper or insomnia.
Participant physical activity levels assessed by fitness tracker data	Baseline, Week 15	Sedentary behavior will be defined as averaging \<5000 steps/day, physically active will be defined as averaging \>7500 steps/day, and consistent physical activity will be defined as a greater reduction in the daily step count standard deviation at baseline compared to the week 15 assessment.
Physical activity (PA) as assessed the International Physical Activity Questionnaire (IPAQ) - Short Form.	Baseline, Week 15	The IPAQ is a 7-item self-report on physical activity. Minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080

Trial Locations

Locations (3)

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States