Evidence map›Paper›PMID 39627155›Full record

Trial reportRespirology (Carlton, Vic.)2025

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

Joshua J Solomon, Robert W Hallowell, Cecilia Ganslandt, Jessica G Shull, Thomas Bengtsson, Jakob Ganslandt, Maureen R Horton

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Respirology (Carlton, Vic.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Joshua J SolomonCenter for Interstitial Lung Disease, National Jewish Health, Denver, Colorado, USA.
Robert W HallowellDivision of Pulmonary and Critical Care, Massachusetts General Hospital, Boston, Massachusetts, USA.
Cecilia GanslandtVicore Pharma, Stockholm, Sweden.
Jessica G ShullVicore Pharma, Stockholm, Sweden.ORCID 0000-0002-3958-8249
Thomas BengtssonVicore Pharma, Stockholm, Sweden.
Jakob GanslandtVicore Pharma, Stockholm, Sweden.
Maureen R HortonJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivePulmonary 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.

methodsCOMPANION 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.

resultsIn 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).

conclusionTreatment 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.

Indexed as

AnxietyAnxiety DisordersCognitive Behavioral TherapyPulmonary FibrosisAgedFemaleHumansMaleMiddle AgedTreatment Outcomeanxietycognitive behavioural therapyinterstitial lung diseasepulmonary fibrosisquality of life

Identifiers

PMID39627155
PMCPMC11872283

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.