Actively Recruiting
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
Led by Boston University Charles River Campus · Updated on 2025-03-14
95
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experienced an acute cardiovascular disease (CVD) event such as myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, or congestive heart failure with hospitalization
- Clinical levels of generalized anxiety disorder symptoms with a GAD-7 score of 10 or higher
- Age 18 years or older
- At least 2 months post an acute cardiac event (post-acute phase)
You will not qualify if you...
- Not English literate
- No access to a digital device
- Severe vision impairment
- Severe cognitive impairment
- Pending acute surgery or life expectancy less than 6 months
- Self-reported schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder (except nicotine)
- Started or changed psychotropic medication dose within the last 4 weeks
- Received cognitive behavioral therapy for anxiety within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston University
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
M
Marie Parsons, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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