Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

NCT Number	NCT04895995
Lead Sponsor	Boston University Charles River Campus
Conditions	Anxiety Disorders, Cardiovascular Diseases, Anxiety, Health Behavior
Enrollment	95 participants
Start Date	2022-02-02
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-03-15 (estimated)
Updated on ClinicalTrials.gov	2025-03-14