Cystic Fibrosis Wellness Program for Adults with Fatigue
CF Wellness Program: ORBIT Phase 2 Pilot RCT
This pilot randomized trial will try a combined cognitive behavioral therapy and physical activity coaching program to see if it helps adults with cystic fibrosis who have significant fatigue sleep better, move more, and sit less.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 3 sites (Denver, Colorado and 2 other locations) |
| Trial ID | NCT07071324 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial will enroll 80 adults with CF and clinically significant fatigue and randomize them to the CF Wellness Program (CFWP) or usual care. The CFWP combines written materials with up to eight virtual coaching sessions that deliver cognitive behavioral therapy techniques alongside a personalized physical activity plan, while objective sleep and activity are collected via fitness trackers. Primary aims are to measure intervention adherence, study retention at week 15, and the quality of daytime and nighttime fitness tracker data, with secondary aims to gather preliminary signals on fatigue, sleep quality, physical activity, and sedentary behavior. The study is conducted at Johns Hopkins, Boston Children's Hospital, and National Jewish Health and requires participants to receive CF care at a participating center and have internet-capable devices for virtual sessions.
Who should consider this trial
Good fit: Adults (≥18) with documented cystic fibrosis who report clinically significant fatigue (Fatigue Severity Scale >4), receive care at a participating CF center, can use a smartphone/tablet/computer, and can safely engage in light physical activity are ideal candidates.
Not a fit: Patients with a recent pulmonary exacerbation, contraindications to light physical activity, who are pregnant or within six months postpartum, or who cannot complete virtual coaching sessions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this program could reduce fatigue, improve sleep quality, and increase physical activity for adults with CF, potentially improving overall physical and mental health.
How similar studies have performed: Cognitive behavioral therapy and increased physical activity have shown benefits for insomnia, fatigue, and sleep in other populations, but this specific combined CBT+PA program has not been previously tested in adults with cystic fibrosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Denver, Colorado and 2 other locations
- National Jewish Health — Denver, Colorado, United States (Not_yet_recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Kristin Riekert, PhD — Johns Hopkins University
- Study coordinator: Kristin Riekert, PhD
- Email: kriekert@jhmi.edu
- Phone: 4105507755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.