A new clinical study assessing the effect of digital cognitive behavioral therapy in patients with idiopathic pulmonary fibrosis (IPF) enrolled its first participant in its US pilot phase.
The study called COMPANION is sponsored by Vicore Pharma and is a fully digitalized, randomized, controlled parallel-group trial that aims to evaluate the impact of the digital therapy Almee™. It consists of 2 parts. The first is a pilot study that will evaluate the functionality of digital therapy, which will be followed by a pivotal study.
Almee is an investigational medical device pending clearance from the US Food and Drug Administration based on cognitive behavioral therapy, which addresses the psychological impact of living with IPF. Research has shown that the majority of patients with IPF experience moderate to severe anxiety due to a short life expectancy and worsening fatigue, cough, and dyspnea.
Read more about IPF comorbidities including the effect of the disease on mental health.
“We are very excited to have randomized our first patient in the pilot phase of the COMPANION study,” said Maureen Horton, MD, principal investigator of COMPANION, in a press release. “This study will not only help to elucidate the effect of anxiety on IPF patients’ quality of life, it will also explore the benefits of cutting edge digital treatment.”
The study aims to enroll 270 patients with IPF, aged 22 years and above in the US and is estimated to be completed in March 2023. The primary outcome measure of part 1 is the patient satisfaction with the functionality of the digital cognitive behavioral therapy based on semistructured interviews. The primary outcome measure of part 2 is the change from baseline in total Generalized Anxiety Disorder 7-item total score.
Secondary outcome measures are changes from baseline in 9-item Patient Health Questionnaire total score and baseline King’s Brief Interstitial Lung Disease questionnaire psychological domain total score and total score.
The US pivotal phase of the study is expected to start in the second half of 2022 and Almee is expected to be made available to patients in 2024.
Vicore launches COMPANION, a clinical study investigating the benefit of digital therapy on anxiety in patients with idiopathic pulmonary fibrosis (IPF). News release. Vicore Pharma; April 21, 2022.
Controlled investigation to evaluate impact of dCBT in adult subjects with IPF (COMPANION). US National Library of Medicine. Updated April 15, 2022. Accessed April 26, 2022.