CF Wellness Program

Last updated: January 12, 2026
Sponsor: Johns Hopkins University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Insomnia

Cystic Fibrosis

Pain (Pediatric)

Treatment

CF Wellness Program

Clinical Study ID

NCT07071324
IRB00496586
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Pulmonary exacerbation (physician determined and may include oral antibiotics, IVantibiotics, 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 physicianand 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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: CF Wellness Program
Phase:
Study Start date:
March 01, 2026
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • National Jewish Health

    Denver 5419384, Colorado 5417618 80206
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

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