CF Wellness Program

Part of paid clinical trials in Denver, Colorado.

Sponsor
Johns Hopkins University
Study ID
NCT07071324
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • No Intervention: Usual Care
    Usual clinical care

Primary Outcome Measure

Intervention Adherence as assessed by the number of CFWP participants [ Time Frame: Up to 15 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206
Christina Bathgate, PhD
[email protected]
303-270-2734
Johns Hopkins UniversityBaltimoreMaryland21224
Kristin Riekert, PhD
[email protected]
410-550-7755
Boston Children's HospitalBostonMassachusetts02115
Carolyn Snell, PhD
[email protected]
617-355-1900

Find similar trials in Denver, CO

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
National Jewish Health· Denver, COJohns Hopkins University· Baltimore, MDBoston Children's Hospital· Boston, MA

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