CF Wellness Program

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

First listed

Jul 17, 2025

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

• Kristin Riekert, PhD
  4105507755
  [email protected]
• Annice Brown
  [email protected]

Locations (3)

Find similar trials in Denver, CO

Related Studies

• Behavioral and Neural Representations of Subjective Effort Cost
  Recruiting · Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Baltimore, Maryland
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Little Rock, Arkansas
• The Effect of Sleep Loss on Emotion Regulation
  Recruiting · Beth Israel Deaconess Medical Center · Boston, Massachusetts
• CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
  Recruiting · Johns Hopkins University · Eglin Air Force Base, Florida