Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
- Conditions
- Pulmonary FibrosisAnxiety
- Interventions
- Device: Digital cognitive behavioral therapy
- Registration Number
- NCT05330312
- Lead Sponsor
- Vicore Pharma AB
- 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.
The study is decentralized and participation is not limited to patients living close to the sites.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 108
- Age ≥22 years at the time of signing the informed consent
- Diagnosis of Pulmonary Fibrosis
- 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 enrollment
- 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
- Self-reported manic disorders, psychotic disorders, suicidal ideation, schizophrenia, self-harm, or alcohol/drug abuse during the past 6 months prior to baseline
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 - Digital cognitive behavioral therapy Digital cognitive behavioral therapy 4 weeks digital cognitive behavioral therapy. Part 2 - Digital cognitive behavioral therapy Digital cognitive behavioral therapy 9 weeks digital cognitive behavioral therapy
- Primary Outcome Measures
Name Time Method Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 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. 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 Outcome Measures
Name Time Method Part 1 - Safety of dCBT-PF-in Patients With IPF Baseline to week 4 Information on AEs, ADEs, SAEs, SADE and device deficiencies which could lead to an ADE or SADE was collected at visits at week 2 and 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 The questionnaire includes 14 questions rating the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) will be summed up to give a total possible score of 0 to 56, where lower scores indicate less anxiety.
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 The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.
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 The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.
Trial Locations
- Locations (2)
Curebase Study Site
🇺🇸San Francisco, California, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States