Digital CBT shows promise in pulmonary fibrosis-related anxiety

Treatment with a digital cognitive behavioural therapy (CBT), dubbed Almee, demonstrates a clinically meaningful improvement in pulmonary fibrosis (PF)-related anxiety and is well-tolerated by patients, reports a study.

"Almee shows promise as a personalized intervention for management of the psychological burden related to living with pulmonary fibrosis,” the investigators said.

A randomized, controlled, open-label and partly reader-blinded trial was conducted in the US to assess the anxiolytic efficacy of Almee in PF patients compared to treatment as usual. Those with radiology-confirmed PF and a Generalized Anxiety Disorder 7-item (GAD-7) score of ≥5 were included.

Between 20 December 2022 and 14 August 2023, the investigators randomly allocated 108 eligible participants to Almee (n=54) or no intervention (n=54) for 9 weeks, with block stratification by anxiety severity. Change in GAD-7 score from baseline to week 9 was the primary endpoint.

Of the participants, 46 completed the study in each arm. All 108 patients were analysed as intention-to-treat. [Respirology 2025;30:253-261]

Average GAD-7 score by week 9 improved by 1.8 points (SEM=2.1) in the Almee group and further decreased by 0.9 point (SEM=2.2) in the control group, with a difference of 2.7 points (95 percent confidence interval, 1.2–4.2; p=0.0006).

“Improved well-being in response to the given treatment may also have extended to improved health-related quality of life, suggested by the effects on the King's Brief Interstitial Lung Disease (K-BILD) total score and psychological domain score favouring Almee,” the investigators said.

Long-term effect

The improvement on the K-BILD psychological domain was also clinically meaningful, but it did not reach statistical significance due to inadequate statistical power to push through the full secondary endpoint hierarchy, according to the investigators. [Respir Res 2020;21:91; Eur Respir J 2019;54:1900281]

These findings show the potential of Almee as a “personalized and accessible intervention for PF patients.” The digital CBT provides tools that help manage thoughts and behaviours, which help patients to cope with disease-related stressors and symptoms, as well as improve their psychological wellbeing.

The extended beneficial effects of Almee through week 12 align with the well-established long-term CBT efficacy, with lasting impact after end of treatment. [Depress Anxiety 2018;35:502-514]

This further suggests that “Almee has potential to produce longer-lasting effects on [the] participants’ daily life, in addition to more immediate symptom reduction during treatment without the side effects of pharmacologic treatments,” the investigators said.

Of note, the positive effects on anxiety first appeared after 3 weeks of treatment. However, there was limited separation between the Almee and the control groups at weeks 3 and 6 before a clear treatment effect was observed by week 9, according to the investigators.

"Delayed improvement is a frequent property of anxiety treatment and occurs in both pharmacological and traditional-CBT treatments,” they said. [Depress Anxiety 2019;36:198-212; Cogn Behav Ther 2020;49:439-454]

PF, a manifestation of interstitial lung disease, is associated with anxiety.