Effects on life satisfaction using a digital therapy in individuals with pulmonary fibrosis – randomised controlled investigation

<bold>Introduction:</bold> Pulmonary fibrosis (PF), a manifestation of interstitial lung disease, is a devastating condition with significant impact on quality of life (QoL). Almee, a digital cognitive behavioral therapy (CBT), was developed to alleviate the psychological burden of living with PF. <bold>Objectives:</bold> The aim of the current analysis was to evaluate the effect of Almee on general life satisfaction and QoL in patients with PF in the United States. <bold>Methods:</bold> COMPANION was a 9-week, randomized, controlled, open label, decentralized, clinical study. Primary endpoint was change in anxiety symptom severity. Key secondary endpoints included change in health-related QoL as measured by KBILD. Change in life satisfaction was explored using BBQ*, a 12-item questionnaire assessing QoL in 6 areas (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) on a 5-point scale, to supplement the disease-specific assessment of KBILD. <bold>Results:</bold> 108 participants were enrolled, 54 in each arm. Almee met its primary endpoint of anxiety reduction (p=0.0006) and improvements in health-related QoL using KBILD were observed (including in subgroups of PF patients on/off anxiolytics/antidepressants and on/off antifibrotics). BBQ score improved significantly over control by 6.5 points (95% CI: 0.6 to 12.4, p=0.0305). Improvement in BBQ correlated with improvements in KBILD. <bold>Conclusions:</bold> In addition to effects on health-related QoL, use of Almee improved general life satisfaction in patients with PF. Almee can be a valuable adjunct to other therapeutic modalities in PF and lead to significant improvements in health-related QOL. *Brunnsviken Brief QOL scale