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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vicore Pharma AB
- Enrollment
- 119
- Locations
- 2
- Primary Endpoint
- Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
HAM-A raters are blinded (HAM-A = Hamilton Anxiety Rating Scale).
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Part 2 - Control group
No intervention
Part 2 - Digital cognitive behavioral therapy
9 weeks digital cognitive behavioral therapy
Intervention: Digital cognitive behavioral therapy (Device)
Part 1 - Digital cognitive behavioral therapy
4 weeks digital cognitive behavioral therapy.
Intervention: Digital cognitive behavioral therapy (Device)
Outcomes
Primary Outcomes
Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
Time Frame: Baseline to Week 4
Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide.
Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.
Time Frame: Baseline to Week 9
The questionnaire includes 7 questions. Each question will be scored on a 4-point scale from 0 to 3 points. Higher score will mean a worse outcome. The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three (0=Not at all,1=Several days, 2=More than half the days and 3=Nearly every day). The composite score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.
Secondary Outcomes
- Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9.(Baseline to Week 9)
- Part 1 - Safety of dCBT-PF-in Patients With IPF(Baseline to week 4)
- Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9(Baseline to Week 9)
- Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9.(Baseline to Week 9)