RecruitingNot ApplicableNCT07071324

CF Wellness Program

CF Wellness Program: ORBIT Phase 2 Pilot RCT

Sponsor

Johns Hopkins University

Enrollment

80 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Sleep Quality Fatigue Cystic Fibrosis (CF)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called CF Wellness Program for people with cystic fibrosis (cf), fatigue, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCF 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.