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Behavioural Intervention
Digital cognitive behavioral therapy for Generalized Anxiety Disorder (COMPANION Trial)
N/A
Waitlist Available
Led By Maureen Horton, MD
Research Sponsored by Vicore Pharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 1 day
Treatment 12 weeks
Follow Up week 4 (part 1) and week 9 (part 2)
Awards & highlights
COMPANION Trial Summary
This trial will test whether digital CBT is an effective, safe treatment for patients with idiopathic pulmonary fibrosis who are struggling with anxiety and depression.
Eligible Conditions
- Generalized Anxiety Disorder
- Pulmonary Fibrosis
COMPANION Trial Timeline
Screening ~ 1 day5 visits
Treatment ~ 12 weeks5 visits
Follow Up ~ week 4 (part 1) and week 9 (part 2)
Screening ~ 1 day
Treatment ~ 12 weeks
Follow Up ~week 4 (part 1) and week 9 (part 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Qualitative patient satisfaction with functionality of dCBT-IPF based on a semi-structured interview
Part 2: Change in anxiety symptom severity assessed by generalized anxiety disorder 7-item (GAD-7)
Secondary outcome measures
Part 2: Change in anxiety symptom severity assessed by Hamilton anxiety rating scale (HAM-A)
Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological domain score
Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological total score
Other outcome measures
Therapeutic procedure
COMPANION Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital cognitive behavioral therapyExperimental Treatment1 Intervention
Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy.
Group II: Control groupActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Curebase, Inc.UNKNOWN
3 Previous Clinical Trials
1,714 Total Patients Enrolled
Vicore Pharma ABLead Sponsor
9 Previous Clinical Trials
711 Total Patients Enrolled
Curebase Inc.Industry Sponsor
6 Previous Clinical Trials
3,481 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05330312 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any ongoing opportunities to join this trial?
"According to clinicaltrials.gov, this medical experiment is actively seeking participants; it was first announced on April 17th 2022 and most recently updated on October 24th of the same year."
Answered by AI
How many volunteers are involved in this medical study?
"Affirmative. According to records on clinicaltrials.gov, this medical study is currently enrolling suitable individuals. It was first posted in April 17th 2022 and the most recent edits were made October 24th 2022. 260 subjects must be sourced from a single site for full participation in the trial."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Curebase Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
I am suffering from these symptoms and would like to see where I stand.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Curebase Study Site: < 48 hours
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