BACKGROUND AND OBJECTIVE: Pulmonary fibrosis, a manifestation of interstitial lung disease, is frequently associated with anxiety. The objective of this study, COMPANION, was to assess the anxiolytic efficacy of Almee, a digital cognitive behavioural therapy for patients with pulmonary fibrosis, compared to treatment as usual. METHODS: COMPANION was a randomized, controlled, open-label and partly reader-blinded, decentralized, clinical trial conducted in the United States. Eligible patients had radiology-confirmed pulmonary fibrosis and a Generalized Anxiety Disorder 7-item (GAD-7) score of ≥5 (possible range 0-21). Participants were randomized 1:1 to Almee or no intervention for 9 weeks, with block stratification by anxiety severity. The primary endpoint was change in GAD-7 score from baseline to week 9. Between 20 December 2022 and 14 August 2023, 108 participants were randomized, 54 to Almee and 54 to treatment as usual. RESULTS: In each arm, 46 participants completed the study
108 cases were analysed as intention-to-treat. By week 9, average GAD-7 score had improved by 1.8 points (SEM = 2.1) in the Almee group (n = 54) and deteriorated by 0.9 points (SEM = 2.2) in the control group (n = 54), a 2.7-point difference (95% confidence interval: 1.2-4.2, p = 0.0006). CONCLUSION: Treatment with Almee was well-tolerated and showed clinically meaningful improvement in pulmonary fibrosis-related anxiety. Almee shows promise as a personalized intervention for management of the psychological burden related to living with pulmonary fibrosis.