CF Wellness Program for Fatigue and Sleep in Cystic Fibrosis - ORBIT Phase 2 Study

Cystic fibrosis (CF) patients often struggle with debilitating fatigue and poor sleep quality, even with modern highly effective modulator therapies (HEMT). This important clinical trial evaluates a novel CF Wellness Program (CFWP) combining cognitive behavioral therapy (CBT) and physical activity coaching to address these overlooked symptoms.

The study builds on concerning findings that 43% of CF adults experience elevated fatigue and 63% report poor sleep quality despite HEMT treatment. These symptoms significantly impact quality of life and disease outcomes. The CFWP offers a structured 8-session virtual program covering:

• Fatigue management strategies
• Sleep improvement techniques
• Personalized physical activity planning
• Emotional wellbeing support
• Stress reduction methods

As a randomized controlled trial, the study will compare 80 participants receiving either the CFWP intervention or usual care. Researchers will track session attendance, collect fitness tracker data, and measure changes in fatigue (using FACIT-F scale), sleep quality (PSQI and ISI), and activity levels.

For CF patients and caregivers, this research addresses critical gaps in holistic care. While HEMT drugs target lung function, many patients continue experiencing "invisible symptoms" like exhaustion and insomnia that dramatically affect daily life. The virtual delivery format makes the program potentially accessible to patients across different locations.

This pilot study represents an important step toward comprehensive CF care. Positive results could establish CBT and activity coaching as standard adjunct therapies. The research team includes leading CF specialists from Johns Hopkins University, National Jewish Health, and Boston Children's Hospital, with funding from the Cystic Fibrosis Foundation.

Future implications may extend beyond CF, as the intervention model could potentially benefit other chronic illnesses where fatigue and sleep disturbances significantly impact quality of life. The study's focus on measurable outcomes and practical delivery methods increases the likelihood that successful results could be quickly implemented in clinical practice.