Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Completed · Not applicable
Conditions studied: Pulmonary Fibrosis, Anxiety
In brief
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.
Key facts
- Study ID
- NCT05330312
- Run by
- Vicore Pharma AB
- People needed
- 119
- Starts
- 2022-04-17
- Expected to finish
- 2023-11-10
- Last updated by the study team
- 2024-09-24
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Curebase Study Site — San Francisco, California, United States
- University of Utah Health — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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