RecruitingNot ApplicableNCT07071324

CF Wellness Program

CF Wellness Program: ORBIT Phase 2 Pilot RCT

Sponsor

Johns Hopkins University

Enrollment

80 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Sleep Quality Fatigue Cystic Fibrosis (CF)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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

Exclusion Criteria6

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

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Interventions

BEHAVIORALCF Wellness Program

Intervention modules are 1) Introduction \& Fatigue Explained, 2) Finding Balance between Activity \& Rest, 3) Physical Activity, Self-Review \& Planning, 4) Improving Your Sleep, 5) Managing Emotions, 6) Changing Less Helpful Thoughts, 7) Learning to Relax \& Manage Stress, and 8) Accessing Social Support and Preparing for the Future.