Cystic Fibrosis Wellness Program for Adults with Fatigue
Official title: CF Wellness Program: ORBIT Phase 2 Pilot RCT
Run by Johns Hopkins University · NCT07071324 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 3 sites (Denver, Colorado and 2 other locations) |
| Status | Recruiting |
| Started | February 3, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07071324 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Johns Hopkins University
Baltimore, Maryland, United States Recruiting -
National Jewish Health
Denver, Colorado, United States Not yet 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.