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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
时间窗: 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.
时间窗: 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.
次要结局
- 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)
- 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)