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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥22 years at the time of signing the informed consent. 2. Diagnosis of Pulmonary Fibrosis. 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 enrollment. 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, suicidal ideation, schizophrenia, self-harm, or alcohol/drug abuse during the past 6 months prior to baseline. 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05330312
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Vicore Pharma AB
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maureen Horton, MD
Principal Investigator Affiliation	Curebase study site
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Generalized Anxiety Disorder, Pulmonary Fibrosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Digital cognitive behavioral therapy

Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy.

No Intervention: Control group

Note: Access to dCBT-PF for the control group will be provided under an Exclusive Release of the product, following completion of the Week 12 visit in the investigation.

Interventions

Device: - Digital cognitive behavioral therapy

Therapy for patients with pulmonary fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Curebase Study Site, San Francisco, California

Status

Recruiting

Address

Curebase Study Site

San Francisco, California, 94118

Site Contact

Study Coordinators

almeestudy@curebase.com

628-261-6287

University of Utah Health, Salt Lake City, Utah

Status