COMPANION - a randomised controlled study to evaluate the impact of a digital therapy on anxiety and quality of life in patients with pulmonary fibrosis

<bold>Introduction:</bold> Pulmonary fibrosis (PF) is a hallmark of interstitial lung disease (ILD) and leads to impaired quality of life (QoL) and significant anxiety. Almee is a personalised digital cognitive behavioral therapy (CBT), easily accessed via a smartphone or tablet, developed to help patients manage the psychological burden of living with PF. <bold>Aims and Objectives:</bold> The COMPANION study was designed to evaluate the efficacy of Almee in reducing anxiety symptoms and improving QoL in PF patients. <bold>Methods:</bold> COMPANION was a 9-week, randomised, waitlist-controlled, open label, decentralised clinical study in individuals with PF confirmed on centrally reviewed computed tomography scan reports. The primary endpoint was change in anxiety symptom severity assessed by General Anxiety Disorder 7 (GAD-7) score. Secondary endpoints included health-related QoL assessed by King's Brief Interstitial Lung Disease (KBILD). <bold>Results:</bold> 108 participants were randomised, 54 in each arm. COMPANION met the primary endpoint of anxiety reduction on GAD-7 (p=0.0006 vs control). Health-related QoL improved as shown by total KBILD score (4.4 points vs control, p = 0.0019) and by all subdomains (psychological 6.5 points, p=0.0015, breathless/activity 4.6 points, p=0.0406, and chest symptoms 5.8 points, p=0.0586). Almee was well-tolerated. <bold>Conclusions:</bold> Almee, the first digital therapy specifically developed for patients with PF, significantly decreased anxiety symptom severity and improved all aspects of health-related QoL, supporting a new comprehensive treatment approach for patients living with this devastating disease.