Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF (COMPANION)

Vicore Pharma

Status: Completed

Conditions: Pulmonary Fibrosis; Anxiety

Treatments: Device: Digital cognitive behavioral therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05330312

VP-dCBT-PF-101

Details and patient eligibility

About

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

Full description

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.

Enrollment: 119 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 3 patient groups

Part 1 - Digital cognitive behavioral therapy

Experimental group

Description:

4 weeks digital cognitive behavioral therapy.

Treatment:

Device: Digital cognitive behavioral therapy

Part 2 - Control group

No Intervention group

Description:

No intervention

Part 2 - Digital cognitive behavioral therapy

Experimental group

Description:

9 weeks digital cognitive behavioral therapy

Treatment:

Device: Digital cognitive behavioral therapy