N/A
Completed N=11
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Source: ClinicalTrials.gov NCT05330312 ↗Enrolled (actual)
11
Serious AEs
12.0%
Results posted
Sep 2024
Primary outcomePrimary: Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 — 8; 2; 2; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 |
8; 2; 2; 1; 3 | — |
| PRIMARY Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9. |
-1.8; 0.9 | — |
| SECONDARY Part 1 - Safety of dCBT-PF-in Patients With IPF |
1 | — |
| SECONDARY Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9 |
-6.7; -4.7 | — |
| SECONDARY Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9. |
8.1; 1.6 | — |
| SECONDARY Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9. |
4.8; 0.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05330312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.