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Completed

NCT Number: NCT05330312

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

The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Curebase Study Site, San Francisco, California, United States

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About this study

Patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Patients will be treated for 9 weeks, followed by a 3 week follow-up period. Efficacy will be assessed after 9 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital cognitive behavioral therapy

Device

Therapy for patients with pulmonary fibrosis

Other names: dCBT-PF

Primary outcomes

  1. Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4

    Time frame: 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.

  2. Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.

    Time frame: 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.

Secondary outcomes

  1. Part 1 - Safety of dCBT-PF-in Patients With IPF

    Time frame: Baseline to week 4

    Information on AEs, ADEs, SAEs, SADE and device deficiencies which could lead to an ADE or SADE was collected at visits at week 2 and week 4.

  2. Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9

    Time frame: Baseline to Week 9

    The questionnaire includes 14 questions rating the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) will be summed up to give a total possible score of 0 to 56, where lower scores indicate less anxiety.

  3. Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9.

    Time frame: Baseline to Week 9

    The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.

  4. Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9.

    Time frame: Baseline to Week 9

    The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.

Sponsors and collaborators

Lead sponsor

Vicore Pharma AB

Industry

Collaborators

  • Curebase Inc.

Registry information

Official study 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

Acronym: COMPANION

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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