Clinical trial NCT05330312: Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Fibrosis
Anxiety
Lead sponsor: Vicore Pharma AB
Sponsor class: INDUSTRY
Collaborators: name: Curebase Inc.
First posted: 2022-04-15
Enrollment: 119
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigation consisted of a Part 1 (pilot phase) with a single arm (4 weeks of dCBT), and a Part 2 (pivotal phase) with a randomised, controlled, parallel-group design to either 9 weeks of dCBT or a control group with no intervention.
Primary purpose: TREATMENT

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 will be assessed after 9 weeks.

Eligibility criteria: Inclusion Criteria:

1. Age ≥22 years at the time of signing the informed consent
2. Self-reported Pulmonary Fibrosis diagnosis
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 baseline
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, schizophrenia, or alcohol/drug abuse during the past 6 months prior to baseline (Visit 1), as judged by the investigator or designee.
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

Primary outcomes:
measure: Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
timeFrame: Baseline to Week 4
measure: Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.
timeFrame: Baseline to Week 9
Secondary outcomes:
measure: Part 1 - Safety of dCBT-PF-in Patients With IPF
timeFrame: Baseline to week 4
measure: Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9
timeFrame: Baseline to Week 9
measure: Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9.
timeFrame: Baseline to Week 9
measure: Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9.
timeFrame: Baseline to Week 9
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Curebase Study Site
state: California
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: Curebase study site
name: Maureen Horton, MD
role: PRINCIPAL_INVESTIGATOR
References: