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NCT Number: NCT07071324

CF Wellness Program

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.

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Key information

Conditions

Cystic Fibrosis (CF) Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Dyssomnias Fatigue Genetic Diseases, Inborn Infant, Newborn, Diseases Insomnia Lung Diseases Mental Disorders Motor Activity Nervous System Diseases Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sedentary Behavior Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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 criteria

  • 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

Treatment and study plan

CF Wellness Program

Behavioral

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 outcomes

  1. Intervention Adherence as assessed by the number of CFWP participants

    Time frame: Up to 15 weeks

    The number of participants randomized to receive the CFWP who complete all 8 coaching sessions.

  2. Participant Retention as assessed by the number of participants completing the week 15 assessment survey

    Time frame: Week 15

    The number of participants across both study groups who complete the week 15 assessment survey.

  3. Fitness Tracker Data Quality as assessed by the number of participants who have valid activity and sleep data.

    Time frame: Baseline, Week 15

    The number of participants who have valid sleep and activity data at the baseline and week 15 assessment. Valid physical and sleep activity was defined as >10 hours of collected data across 4 days, including 1 weekend day and overnight.

Secondary outcomes

  1. Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F)

    Time frame: Baseline, Week 15

    The number of CFWP participants reporting clinically improved fatigue compared to UC participants at the week 15 assessment. The FACIT-F is a 14-question instrument used to assess self-reported fatigue. Scores range from 0-52, with a score of <34 indicating clinically significant fatigue. Lower scores indicate higher fatigue. Clinically improved fatigue is defined as a ≥4 points increase in the FACIT-F or no longer having fatigue (FACIT-F ≥34).

  2. Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 15 weeks

    The PSQI is a 19-item questionnaire that measures an individual's quality of sleep over the last month. Scores range from 0 to 21, with a score >5 indicative of poor sleep quality.

  3. Sleep Quality as assessed by the Insomnia Severity Index (ISI)

    Time frame: Baseline, 15 weeks

    The ISI is a 7-item scale measuring the impact of insomnia in the past month. Total score ranging from 0 to 28, scores are categorized to indicate the severity of insomnia, ranging from no clinically significant insomnia (0-7) to severe insomnia (22-28). Higher score more severe insomnia.

  4. Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C).

    Time frame: Baseline, 15 weeks

    The CSD-C is a 9-item self-reported diary of sleep activity to determine patterns such as good sleeper or insomnia.

  5. Participant physical activity levels assessed by fitness tracker data

    Time frame: Baseline, Week 15

    Sedentary behavior will be defined as averaging <5000 steps/day, physically active will be defined as averaging >7500 steps/day, and consistent physical activity will be defined as a greater reduction in the daily step count standard deviation at baseline compared to the week 15 assessment.

  6. Physical activity (PA) as assessed the International Physical Activity Questionnaire (IPAQ) - Short Form.

    Time frame: Baseline, Week 15

    The IPAQ is a 7-item self-report on physical activity. Minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080

Study contacts

Contact information is provided by the study sponsor or research team.

Annice Brown

CONTACT

[email protected]

Kristin Riekert, PhD

CONTACT

[email protected]

4105507755

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Boston Children's Hospital, Boston, MA, USA
  • Cystic Fibrosis Foundation
  • National Jewish Health

Registry information

Official study title

CF Wellness Program: ORBIT Phase 2 Pilot RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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