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

Generalized Anxiety Disorder Clinical Trial

— COMPANION  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05330312
• Other study ID #: VP-dCBT-PF-101
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2022
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Vicore Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Age =22 years at the time of signing the informed consent

2. Diagnosis of Pulmonary Fibrosis

3. A GAD-7 score of =5 at pre-screening and baseline

4. If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to enrollment

5. CT scan report within 5 years prior to baseline with signs of PF (interstitial changes)

6. Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device

Exclusion Criteria:

1. Self-reported manic disorders, psychotic disorders, suicidal ideation, schizophrenia, self-harm, or alcohol/drug abuse during the past 6 months prior to baseline

2. Self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee

3. Self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee

4. Verbal and/or written communication problems limiting ability to engage with dCBT-IPF

5. Inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee

6. Currently receiving cognitive behavioral therapy

Related Conditions & MeSH terms

• Anxiety Disorders
• Fibrosis
• Generalized Anxiety Disorder
• Pulmonary Fibrosis

Intervention

Device:
• Digital cognitive behavioral therapy
Therapy for patients with pulmonary fibrosis

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah
United States	Curebase Study Site	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Vicore Pharma AB	Curebase Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Part 1 and 2: Frequency of adverse events during treatment with dCBT-PF versus control		Week 4 (Part 1) and Week 9 (Part 2)
Primary	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
Primary	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	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
Secondary	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
Secondary	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