Pulmonary FibrosisCOMPANIONNCT05330312
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
A study testing Digital cognitive behavioral therapy in people with Pulmonary Fibrosis and Anxiety, run by Vicore Pharma AB at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Anxiety
- What is being tested?
- Digital cognitive behavioral therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2022to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah Health
Salt Lake City, Utah, 84025
Curebase Study Site
San Francisco, California, 94118
About this study
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
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.
Read the detailed description
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.
- Conditions
- Pulmonary Fibrosis, Anxiety
- Being tested
- Digital cognitive behavioral therapy
- Medical subject headings
- Pulmonary Fibrosis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cognitive behavioral therapyDevice
Also called dCBT-PF
Therapy for patients with pulmonary fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Digital cognitive behavioral therapy | Experimental | 4 weeks digital cognitive behavioral therapy. Receives: 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 Receives: Device: Digital cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 9
Secondary outcomes (4)
Part 1 - Safety of dCBT-PF-in Patients With IPF
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start17 Apr 2022
- Primary completion19 Oct 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Responsible party
- Sponsor
- Investigators
- Maureen Horton, MD, Principal investigator, Curebase study site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330312
- Sponsor's protocol ID
- VP-dCBT-PF-101
- Acronym
- COMPANION
- Status last verified
- Sep 2024
- First submitted
- 3 Mar 2022
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Solomon JJ, Hallowell RW, Ganslandt C, Shull JG, Bengtsson T, Ganslandt J, Horton MR. A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial. Respirology. 2025 Mar;30(3):253-261. doi: 10.1111/resp.14859. Epub 2024 Dec 3.
PubMed 39627155
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05330312
- Acronym / sponsor ID
- COMPANION / VP-dCBT-PF-101
- Conditions
- Pulmonary Fibrosis, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Digital cognitive behavioral therapy | Experimental | Device: Digital cognitive behavioral therapy4 weeks digital cognitive behavioral therapy. |
| Part 2 - Control group | No intervention | –No intervention |
| Part 2 - Digital cognitive behavioral therapy | Experimental | Device: Digital cognitive behavioral therapy9 weeks digital cognitive behavioral therapy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital cognitive behavioral therapyAlso: dCBT-PFTherapy for patients with pulmonary fibrosis | Device | Part 1 - Digital cognitive behavioral therapy, Part 2 - Digital cognitive behavioral therapy |
Primary outcome
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.
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.
4 secondary outcomes
Part 1 - Safety of dCBT-PF-in Patients With IPF
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39627155Solomon JJ, Hallowell RW, Ganslandt C, Shull JG, Bengtsson T, Ganslandt J, Horton MR. A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial. Respirology. 2025 Mar;30(3):253-261. doi: 10.1111/resp.14859. Epub 2024 Dec 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Horton, MD principal investigator
Curebase study site
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cognitive behavioral therapy in people with Pulmonary Fibrosis and Anxiety, run by Vicore Pharma AB at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 (time frame: Baseline to Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.