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Behavioural Intervention

Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF (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
No Placebo-Only Group

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

Timeline

Screening ~ 1 day
Treatment ~ 12 weeks
Follow Up ~week 4 (part 1) and week 9 (part 2)
This trial's timeline: 1 day for screening, 12 weeks for treatment, and week 4 (part 1) and week 9 (part 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.
Secondary study objectives
Part 1 - Safety of dCBT-PF-in Patients With IPF
Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at 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.
+1 more
Other study objectives
Therapeutic procedure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 - Digital cognitive behavioral therapyExperimental Treatment1 Intervention
9 weeks digital cognitive behavioral therapy
Group II: Part 1 - Digital cognitive behavioral therapyExperimental Treatment1 Intervention
4 weeks digital cognitive behavioral therapy.
Group III: Part 2 - Control groupActive Control1 Intervention
No intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital cognitive behavioral therapy
2022
N/A
~120

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
10 Previous Clinical Trials
969 Total Patients Enrolled
Curebase Inc.Industry Sponsor
6 Previous Clinical Trials
3,481 Total Patients Enrolled
Maureen Horton, MDPrincipal InvestigatorCurebase study site
2 Previous Clinical Trials
297 Total Patients Enrolled

Media Library

Digital Cognitive Behavioral Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330312 — N/A
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05330312 — N/A
~32 spots leftby Jan 2026
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