Cystic Fibrosis (CF)NCT07071324
CF Wellness Program
A study testing CF Wellness Program in people with Cystic Fibrosis (CF) and Fatigue, run by Johns Hopkins University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), Fatigue, Sleep Quality
- What is being tested?
- CF Wellness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Feb 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Annice Brown contact
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21224
Kristin Riekert, PhD, 410-550-7755, kriekert@jhmi.edu
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Carolyn Snell, PhD, 617-355-1900, carolyn.snell@childrens.harvard.edu
- Not yet recruiting
National Jewish Health
Denver, Colorado, 80206
Christina Bathgate, PhD, 303-270-2734, BathgateC@njhealth.org
About this study
Official title: 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.
Read the 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
- Being tested
- CF Wellness Program
- Keywords
- Cystic Fibrosis (CF), Fatigue, Sleep Quality, Physical Activity, Insomnia, Cognitive Behavioral Therapy, Sedentary
- Medical subject headings
- Cystic Fibrosis, Fatigue, Sleep Initiation and Maintenance Disorders, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF Wellness ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Behavioral: CF Wellness Program |
| Usual Care | No intervention | Usual clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 15
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start3 Feb 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Boston, MA, USA, National Jewish Health, Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Kristin Riekert, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071324
- Sponsor's protocol ID
- IRB00496586
- Status last verified
- Feb 2026
- First submitted
- 8 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CF Wellness Program: ORBIT Phase 2 Pilot RCT
- ClinicalTrials.gov ID
- NCT07071324
- Acronym / sponsor ID
- IRB00496586
- Conditions
- Cystic Fibrosis (CF), Fatigue, Sleep Quality, Insomnia
- Keywords
- Cystic Fibrosis (CF), Fatigue, Sleep Quality, Physical Activity, Insomnia, Cognitive Behavioral Therapy, Sedentary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Boston, MA, USA, National Jewish Health, Cystic Fibrosis Foundation
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: CF Wellness ProgramAdults 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. |
| Usual Care | No intervention | –Usual clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF Wellness ProgramIntervention 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. | Behavioural | Treatment Group |
Primary outcome
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.
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.
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.
6 secondary outcomes
Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F)
Time frame: Baseline, Week 15
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 15 weeks
Sleep Quality as assessed by the Insomnia Severity Index (ISI)
Time frame: Baseline, 15 weeks
Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C).
Time frame: Baseline, 15 weeks
Participant physical activity levels assessed by fitness tracker data
Time frame: Baseline, Week 15
Physical activity (PA) as assessed the International Physical Activity Questionnaire (IPAQ) - Short Form.
Time frame: Baseline, Week 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annice Brown contact
Kristin Riekert, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CF Wellness Program in people with Cystic Fibrosis (CF) and Fatigue, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Riekert, PhD (4105507755, kriekert@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Adherence as assessed by the number of CFWP participants (time frame: Up to 15 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.