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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05330312
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : December 14, 2022
Sponsor:
Collaborator:
Curebase Inc.
Information provided by (Responsible Party):
Vicore Pharma AB

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.

The study is decentralized and participation is not limited to patients living close to the sites.


Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Pulmonary Fibrosis Device: Digital cognitive behavioral therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Digital cognitive behavioral therapy
Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy.
Device: Digital cognitive behavioral therapy
Therapy for patients with pulmonary fibrosis
Other Name: dCBT-PF

No Intervention: Control group
Note: Access to dCBT-PF for the control group will be provided under an Exclusive Release of the product, following completion of the Week 12 visit in the investigation.



Primary Outcome Measures :
  1. Part 1: Qualitative patient satisfaction with functionality of dCBT-IPF based on a semi-structured interview [ Time Frame: Week 4 ]
    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.

  2. Part 2: Change in anxiety symptom severity assessed by generalized anxiety disorder 7-item (GAD-7) [ Time Frame: Baseline to Week 9 ]
    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.


Secondary Outcome Measures :
  1. Part 2: Change in anxiety symptom severity assessed by Hamilton anxiety rating scale (HAM-A) [ 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 to 4. The HAM-A total score range from 0 to 56, where a lower scores indicate less anxiety.

  2. Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological domain score [ Time Frame: Baseline to Week 9 ]
    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.

  3. Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological total score [ Time Frame: Baseline to Week 9 ]
    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.


Other Outcome Measures:
  1. Part 1 and 2: Frequency of adverse events during treatment with dCBT-PF versus control [ Time Frame: Week 4 (Part 1) and Week 9 (Part 2) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. PHQ-9 Q9 >0 at pre-screening (indicative of potential 'death wish' or intent to 'self-harm')
  3. A composite PHQ-9 score of ≥20 at pre-screening (indicative of severe depression)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05330312


Contacts
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Contact: Anne Katrine Cohrt +46(0)317880560 info@vicorepharma.com
Contact: Cecilia Ganslandt, M.D. +46(0)317880560 info@vicorepharma.com

Locations
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United States, California
Curebase Study Site Recruiting
San Francisco, California, United States, 94118
Contact: Study Coordinators    628-261-6287    almeestudy@curebase.com   
United States, Utah
University of Utah Health Not yet recruiting
Salt Lake City, Utah, United States, 84025
Contact: Lindsey Waddoups, MS    801-581-5811    lindsey.waddoups@hsc.utah.edu   
Contact: Macy Barrios    801-581-5811    macy.barrios@hsc.utah.edu   
Sponsors and Collaborators
Vicore Pharma AB
Curebase Inc.
Investigators
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Principal Investigator: Maureen Horton, MD Curebase study site
Additional Information:
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Responsible Party: Vicore Pharma AB
ClinicalTrials.gov Identifier: NCT05330312    
Other Study ID Numbers: VP-dCBT-PF-101
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Fibrosis
Anxiety Disorders
Pathologic Processes
Mental Disorders
Lung Diseases
Respiratory Tract Diseases