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

NCT05330312 | Completed Results DMC FDA Device

• 1 other identifier: VP-dCBT-PF-101
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Fibrosis; Anxiety

Outcome Measures

Primary Outcomes (2)

• Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at 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.

  Baseline to Week 4

• Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at 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.

  Baseline to Week 9

Secondary Outcomes (4)

• 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

Study Arms (3)

Part 1 - Digital cognitive behavioral therapy

EXPERIMENTAL

4 weeks digital cognitive behavioral therapy.

Device: Digital cognitive behavioral therapy

Part 2 - Control group

NO INTERVENTION

No intervention

Part 2 - Digital cognitive behavioral therapy

EXPERIMENTAL

9 weeks digital cognitive behavioral therapy

Device: Digital cognitive behavioral therapy

Interventions

Digital cognitive behavioral therapy DEVICE

Therapy for patients with pulmonary fibrosis

Also known as: dCBT-PF

Part 1 - Digital cognitive behavioral therapy; Part 2 - Digital cognitive behavioral therapy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vicore Pharma AB: lead
• Curebase Inc.: collaborator

Study Sites (2)

Curebase Study Site

San Francisco, California, 94118, United States

Location

University of Utah Health

Salt Lake City, Utah, 84025, United States

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Director Clinical Operations
• Organization: Vicore Pharma

info@vicorepharma.com

+46317880560

Study Officials

• Maureen Horton, MD

  Curebase study site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: HAM-A raters are blinded (HAM-A = Hamilton Anxiety Rating Scale).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation consisted of a Part 1 (pilot phase) with a single arm (4 weeks of dCBT), and a Part 2 (pivotal phase) with a randomised, controlled, parallel-group design to either 9 weeks of dCBT or a control group with no intervention.

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 15, 2022
• Study Start: April 17, 2022
• Primary Completion: October 19, 2023
• Study Completion: November 10, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)