The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.

Patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Patients will be treated for 9 weeks, followed by a 3 week follow-up period. Efficacy will be assessed after 9 weeks.

Inclusion Criteria:

1. Age ≥22 years at the time of signing the informed consent
2. Self-reported Pulmonary Fibrosis diagnosis
3. A GAD-7 score of ≥5 at pre-screening and baseline
4. If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to baseline
5. CT scan report within 5 years prior to baseline with signs of PF (interstitial changes)
6. Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device

Exclusion Criteria:

1. Self-reported manic disorders, psychotic disorders, schizophrenia, or alcohol/drug abuse during the past 6 months prior to baseline (Visit 1), as judged by the investigator or designee.
2. Self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee
3. Self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee
4. Verbal and/or written communication problems limiting ability to engage with dCBT-IPF
5. Inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee
6. Currently receiving cognitive behavioral therapy

One subject randomised to dCBT-PF in Part 2 was not treated, as the subject was unable to download the app.

Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.

In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.

HAM-A raters are blinded (HAM-A = Hamilton Anxiety Rating Scale).