Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Generalized Anxiety Disorder, Pulmonary Fibrosis

Intervention / Treatment
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* Device: Digital cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital cognitive behavioral therapy<br>Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy. | Device: Digital cognitive behavioral therapy<br>* Therapy for patients with pulmonary fibrosis<br>* Other names: dCBT-PF;|
| No Intervention: Control group<br>Note: Access to dCBT-PF for the control group will be provided under an Exclusive Release of the product, following completion of the Week 12 visit in the investigation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Qualitative patient satisfaction with functionality of dCBT-IPF based on a semi-structured interview | Based on a patient interview. No scale will be used and the evaluation will be based on the patient's verbally reported satisfaction with dCBT-IPF. | Week 4 | 
| Part 2: Change in anxiety symptom severity assessed by generalized anxiety disorder 7-item (GAD-7) | The questionnaire includes 7 questions. Each question will be scored on a 4-point likert scale from 0 to 3 points. Higher score will mean a worse outcome. | Baseline to Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2: Change in anxiety symptom severity assessed by Hamilton anxiety rating scale (HAM-A) | The questionnaire includes 14 questions rating the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 to 4. The HAM-A total score range from 0 to 56, where a lower scores indicate less anxiety. | Baseline to Week 9 | 
| Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological domain score | The questionnaire includes 15 questions. Each question will be scored on a scale from 1 to 7. The K-BILD total score range will be from 0 to 100 points. Higher score will mean a worse outcome. | Baseline to Week 9 | 
| Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological total score | The questionnaire includes 15 questions. Each question will be scored on a scale from 1 to 7. The K-BILD total score range will be from 0 to 100 points. Higher score will mean a worse outcome. | Baseline to Week 9 |