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Controlled Investigation to Evaluate Impact of dCBT in Adult Subjects With IPF

Study Purpose

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

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 Idiopathic Pulmonary Fibrosis. 3. A 7-item generalized anxiety questionnaire score of ≥5 at baseline. 4. If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to enrollment. 5. Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device.

Exclusion Criteria:

1. Manic disorders, psychotic disorders, suicidal ideation, schizophrenia, self-harm, or alcohol/drug abuse during the past 6 months prior to baseline. 2. Cognitive impairment e.g., dementia preventing engagement with dCBT-IPF. 3. Verbal and/or written communication problems limiting ability to engage with dCBT- IPF. 4. Inability to comply with investigation procedures, due to severe medical conditions or otherwise. 5. Life expectancy of less than 6 months as determined by the need for palliative care. 6. Currently receiving cognitive behavioral therapy. 7. Part 2 only; Prior participation in part 1 of the study

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, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Anxiety Disorder, Depression, Idiopathic 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 treated for 9 weeks with the treatment or will be put in a wait list group (control group), 1:1 ratio.

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

Waitlist control group in part 2 of the study

Interventions

Device: - digital cognitive behavioral therapy

digital cognitive behavioral therapy for patients with idiopathic 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

amicstudy@curebase.com

628-261-6287