Generalized Anxiety Disorder Clinical Trial
Official title:
A Randomized, Controlled, Parallel-group Clinical Investigation Evaluating the Impact of Digital Cognitive Behavioural Therapy on Psychological Symptom Burden in Adults Diagnosed With Pulmonary Fibrosis
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety. The study is decentralized and participation is not limited to patients living close to the sites.
The study consist of two parts (part 1 and part 2). Prior to treatment with the digital therapy all patients will sign an informed consent form and eligibility will be checked. In part 1 eligible patients will be treated for 4 weeks with the treatment. The main purpose of part 1 is to evaluate the functionality of the digital therapy. In part 2 patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Note: The control group will be offered access to the digital therapy, under an Exclusive Release of the product, following completion of the Week 12 visit of the investigation. ;
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