{"doi":"10.1111/resp.14859","title":"A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial","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.","journal":"Respirology","year":2024,"id":443797,"datarank":0.36336995973757236,"base_score":2.1972245773362196,"endowment":2.1972245773362196,"self_citation_contribution":0.32958368660043297,"citation_network_contribution":0.0337862731371394,"self_endowment_contribution":0.32958368660043297,"citer_contribution":0.0337862731371394,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":8,"citers_with_citation_signal":3,"citers_with_endowment":3,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.925,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT05330312"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":857821,"name":"Robert W. Hallowell","orcid":"0000-0001-9386-7700","position":1,"is_corresponding":false},{"id":1258971,"name":"Cecilia Ganslandt","orcid":null,"position":2,"is_corresponding":false},{"id":1258463,"name":"Jessica Shull","orcid":"0000-0002-3958-8249","position":3,"is_corresponding":false},{"id":1258464,"name":"Thomas Bengtsson","orcid":"0000-0002-9667-8873","position":4,"is_corresponding":false},{"id":1258972,"name":"Jakob Ganslandt","orcid":null,"position":5,"is_corresponding":false},{"id":228374,"name":"Maureen R. Horton","orcid":"0000-0002-0621-1015","position":6,"is_corresponding":false},{"id":137081,"name":"Joshua J. Solomon","orcid":"0000-0001-5488-4874","position":0,"is_corresponding":true}],"reference_count":31,"raw_metadata":null,"created_at":"2026-07-19T02:01:29.001453Z","pmid":"39627155","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}