A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial.

ABSTRACT:

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 s

SUBMITTER: Solomon JJ 

PROVIDER: S-EPMC11872283 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature