Joshua J Solomon, Robert W Hallowell, Cecilia Ganslandt, Jessica G Shull, Thomas Bengtsson, Jakob Ganslandt, Maureen R Horton
{"title":"A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial.","authors":"Joshua J Solomon, Robert W Hallowell, Cecilia Ganslandt, Jessica G Shull, Thomas Bengtsson, Jakob Ganslandt, Maureen R Horton","doi":"10.1111/resp.14859","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":21129,"journal":{"name":"Respirology","volume":" ","pages":""},"PeriodicalIF":6.6000,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Respirology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/resp.14859","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
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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 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.
期刊介绍:
Respirology is a journal of international standing, publishing peer-reviewed articles of scientific excellence in clinical and clinically-relevant experimental respiratory biology and disease. Fields of research include immunology, intensive and critical care, epidemiology, cell and molecular biology, pathology, pharmacology, physiology, paediatric respiratory medicine, clinical trials, interventional pulmonology and thoracic surgery.
The Journal aims to encourage the international exchange of results and publishes papers in the following categories: Original Articles, Editorials, Reviews, and Correspondences.
Respirology is the preferred journal of the Thoracic Society of Australia and New Zealand, has been adopted as the preferred English journal of the Japanese Respiratory Society and the Taiwan Society of Pulmonary and Critical Care Medicine and is an official journal of the World Association for Bronchology and Interventional Pulmonology.