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

IF 6.6 2区 医学 Q1 RESPIRATORY SYSTEM Respirology Pub Date : 2025-03-01 Epub Date: 2024-12-03 DOI:10.1111/resp.14859
Joshua J Solomon, Robert W Hallowell, Cecilia Ganslandt, Jessica G Shull, Thomas Bengtsson, Jakob Ganslandt, Maureen R Horton
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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.

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针对肺纤维化患者焦虑的数字疗法:一项分散的随机对照试验。
背景和目的:肺纤维化是肺间质性疾病的一种表现,常与焦虑相关。这项名为COMPANION的研究的目的是评估Almee的抗焦虑效果,Almee是一种用于肺纤维化患者的数字认知行为疗法,与常规治疗相比。方法:COMPANION是一项在美国进行的随机、对照、开放标签、部分读者盲、分散的临床试验。符合条件的患者有影像学证实的肺纤维化和广泛性焦虑障碍7项(GAD-7)评分≥5(可能范围0-21)。参与者以1:1的比例随机分为Almee组或无干预组,为期9周,并根据焦虑严重程度进行分组分层。主要终点是GAD-7评分从基线到第9周的变化。在2022年12月20日至2023年8月14日期间,108名参与者被随机分组,54名接受Almee治疗,54名接受常规治疗。结果:在每组中,46名参与者完成了研究;108例进行意向治疗分析。到第9周,Almee组(n = 54)的平均GAD-7评分提高了1.8分(SEM = 2.1),对照组(n = 54)的平均GAD-7评分下降了0.9分(SEM = 2.2),差异为2.7分(95%可信区间:1.2-4.2,p = 0.0006)。结论:Almee治疗耐受性良好,对肺纤维化相关焦虑有临床意义的改善。Almee有望作为一种个性化干预治疗与肺纤维化相关的心理负担。
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来源期刊
Respirology
Respirology 医学-呼吸系统
CiteScore
10.60
自引率
5.80%
发文量
225
审稿时长
1 months
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.
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