Solomon Joshua J, Hallowell Robert W, Ganslandt Cecilia, Shull Jessica G, Bengtsson Thomas, Ganslandt Jakob, Horton Maureen R
Center for Interstitial Lung Disease, National Jewish Health, Denver, Colorado, USA.
Division of Pulmonary and Critical Care, Massachusetts General Hospital, Boston, Massachusetts, USA.
Respirology. 2025 Mar;30(3):253-261. doi: 10.1111/resp.14859. Epub 2024 Dec 3.
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.
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.
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).
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.
肺纤维化是间质性肺疾病的一种表现，常与焦虑相关。本研究COMPANION的目的是评估Almee（一种针对肺纤维化患者的数字认知行为疗法）与常规治疗相比的抗焦虑疗效。
COMPANION是一项在美国进行的随机、对照、开放标签且部分读者盲法、去中心化的临床试验。符合条件的患者经放射学确诊为肺纤维化，且广泛性焦虑障碍7项量表（GAD - 7）评分≥5分（可能范围为0 - 21分）。参与者按1:1随机分为Almee组或9周不干预组，按焦虑严重程度进行区组分层。主要终点是从基线到第9周GAD - 7评分的变化。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。
每组均有46名参与者完成研究；108例按意向性分析。到第9周时，Almee组（n = 54）的平均GAD - 7评分改善了1.8分（标准误 = 2.1），而对照组（n = 54）恶化了0.9分（标准误 = 2.2），差异为2.7分（95%置信区间：1.2 - 4.2，p = 0.0006）。
Almee治疗耐受性良好，在肺纤维化相关焦虑方面显示出有临床意义的改善。Almee有望作为一种个性化干预措施，用于管理与肺纤维化生活相关的心理负担。
