Recruiting

CF Wellness Program

Sponsor:

Johns Hopkins University

Code:

NCT07071324

Conditions

Cystic Fibrosis (CF)

Fatigue

Sleep Quality

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CF Wellness Program

Study Details

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.

Conditions

Cystic Fibrosis (CF)

Fatigue

Sleep Quality

Insomnia

Study ID

NCT07071324

Start date

Feb 3, 2026

Status verified date

Feb, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Adults With Cystic Fibrosis (AWCF) randomized to the intervention will receive the CFWP written materials and be offered up to 8 coaching sessions tailored to fatigue, physical activity, and mental well-being. The sessions will last approximately 45 - 60 minutes and be delivered either by web-based video chat (e.g., Zoom) or by telephone.

no intervention: Usual Care

Usual clinical care

Interventions

CF 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.

Primary outcome measure

  • Intervention Adherence as assessed by the number of CFWP participants [ Time Frame: Up to 15 weeks ]
  • Participant Retention as assessed by the number of participants completing the week 15 assessment survey [ Time Frame: Week 15 ]
  • Fitness Tracker Data Quality as assessed by the number of participants who have valid activity and sleep data. [ Time Frame: Baseline, Week 15 ]

Central Contacts and Locations

Central contacts

Kristin Riekert, PhD

4105507755kriekert@jhmi.edu

Annice Brown

abrow272@jh.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Kristin Riekert, PhD

410-550-7755kriekert@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • Cystic Fibrosis (CF)
  • Fatigue
  • Sleep Quality
  • Physical Activity
  • Insomnia
  • Cognitive Behavioral Therapy
  • Sedentary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-13.