Status:
COMPLETED
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Lead Sponsor:
Vicore Pharma AB
Collaborating Sponsors:
Curebase Inc.
Conditions:
Pulmonary Fibrosis
Anxiety
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.
Detailed 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 ...
Eligibility Criteria
Inclusion
- Age ≥22 years at the time of signing the informed consent
- Self-reported Pulmonary Fibrosis diagnosis
- A GAD-7 score of ≥5 at pre-screening and baseline
- If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to baseline
- CT scan report within 5 years prior to baseline with signs of PF (interstitial changes)
- Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device
Exclusion
- 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.
- Self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee
- Self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee
- Verbal and/or written communication problems limiting ability to engage with dCBT-IPF
- Inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee
- Currently receiving cognitive behavioral therapy
Key Trial Info
Start Date :
April 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05330312
Start Date
April 17 2022
End Date
November 10 2023
Last Update
September 24 2024
Active Locations (2)
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1
Curebase Study Site
San Francisco, California, United States, 94118
2
University of Utah Health
Salt Lake City, Utah, United States, 84025