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

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 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)

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: 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 study objectives

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 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

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.

Do I qualify?Apply below to find out