CF Wellness Program

NCT ID: NCT07071324

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-03
• Study Completion Date: 2028-06-30

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.

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.

Conditions

Cystic Fibrosis (CF); Fatigue; Sleep Quality; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CF Wellness Program

Intervention Type: 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.

Usual Care

Usual clinical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital, Boston, MA, USA

OTHER

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Riekert, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

National Jewish Health

Denver, Colorado, United States

Site Status: NOT_YET_RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Kristin Riekert, PhD

Role: CONTACT

kriekert@jhmi.edu

4105507755

Annice Brown

Role: CONTACT

abrow272@jh.edu

Facility Contacts

Christina Bathgate, PhD

Role: primary

BathgateC@njhealth.org

303-270-2734

Kristin Riekert, PhD

Role: primary

kriekert@jhmi.edu

410-550-7755

Carolyn Snell, PhD

Role: primary

carolyn.snell@childrens.harvard.edu

617-355-1900

Other Identifiers

IRB00496586

Identifier Type: -

Identifier Source: org_study_id