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

Primary Purpose

Generalized Anxiety Disorder, Pulmonary Fibrosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital cognitive behavioral therapy
Sponsored by
Vicore Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Curebase Study Site
  • University of Utah Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital cognitive behavioral therapy

Control group

Arm Description

Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 3, 2022
Last Updated
August 28, 2023
Sponsor
Vicore Pharma AB
Collaborators
Curebase Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05330312
Brief Title
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vicore Pharma AB
Collaborators
Curebase Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Digital cognitive behavioral therapy
Other Intervention Name(s)
dCBT-PF
Intervention Description
Therapy for patients with pulmonary fibrosis
Primary Outcome Measure Information:
Title
Part 1: Qualitative patient satisfaction with functionality of dCBT-IPF based on a semi-structured interview
Description
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.
Time Frame
Week 4
Title
Part 2: Change in anxiety symptom severity assessed by generalized anxiety disorder 7-item (GAD-7)
Description
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.
Time Frame
Baseline to Week 9
Secondary Outcome Measure Information:
Title
Part 2: Change in anxiety symptom severity assessed by Hamilton anxiety rating scale (HAM-A)
Description
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.
Time Frame
Baseline to Week 9
Title
Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological domain score
Description
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.
Time Frame
Baseline to Week 9
Title
Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological total score
Description
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.
Time Frame
Baseline to Week 9
Other Pre-specified Outcome Measures:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥22 years at the time of signing the informed consent Diagnosis of Pulmonary Fibrosis 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 enrollment 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, suicidal ideation, schizophrenia, self-harm, or alcohol/drug abuse during the past 6 months prior to baseline 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Horton, MD
Organizational Affiliation
Curebase study site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curebase Study Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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