CF Wellness Program

CF Wellness Program: ORBIT Phase 2 Pilot RCT

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.

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Insomnia; Sleep Quality; Cystic Fibrosis (CF)
• Intervention / Treatment: Behavioral: CF Wellness Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Riekert, PhD; Phone Number: 4105507755; Email: kriekert@jhmi.edu
• Study Contact Backup: Name: Annice Brown; Email: abrow272@jh.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • Not yet recruiting
      • National Jewish Health
      • Contact: Christina Bathgate, PhD; Phone Number: 303-270-2734; Email: BathgateC@njhealth.org
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins University
      • Contact: Kristin Riekert, PhD; Phone Number: 410-550-7755; Email: kriekert@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Boston Children's Hospital
      • Contact: Carolyn Snell, PhD; Phone Number: 617-355-1900; Email: carolyn.snell@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual clinical care
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Adherence as assessed by the number of CFWP participants	The number of participants randomized to receive the CFWP who complete all 8 coaching sessions.	Up to 15 weeks
Participant Retention as assessed by the number of participants completing the week 15 assessment survey	The number of participants across both study groups who complete the week 15 assessment survey.	Week 15
Fitness Tracker Data Quality as assessed by the number of participants who have valid activity and sleep data.	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.	Baseline, Week 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F)	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).	Baseline, Week 15
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)	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.	Baseline, 15 weeks
Sleep Quality as assessed by the Insomnia Severity Index (ISI)	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.	Baseline, 15 weeks
Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C).	The CSD-C is a 9-item self-reported diary of sleep activity to determine patterns such as good sleeper or insomnia.	Baseline, 15 weeks
Participant physical activity levels assessed by fitness tracker data	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.	Baseline, Week 15
Physical activity (PA) as assessed the International Physical Activity Questionnaire (IPAQ) - Short Form.	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	Baseline, Week 15

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Cystic Fibrosis Foundation; National Jewish Health; Boston Children's Hospital, Boston, MA, USA
• Investigators: Principal Investigator: Kristin Riekert, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 8, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Fatigue; Insomnia; Sleep Quality; Cognitive Behavioral Therapy; Sedentary; Cystic Fibrosis (CF)
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Fatigue; Sleep Initiation and Maintenance Disorders; Cystic Fibrosis; Motor Activity; Sedentary Behavior
• Other Study ID Numbers: IRB00496586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No