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

NCT04895995 · Boston University Charles River Campus

Recruiting

In plain English

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About this study

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. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, 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). Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).

Eligibility criteria

Inclusion Criteria: * Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial fibrillation, and other arrhythmias) * Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7 * Age 18 or older. * Individuals must be in the post-acute phase of their CVD; this is operationalized as \> 2 months post an acute cardiac event. Exclusion Criteria: * Non-English speaker/literate * No access to a digital device * Severely vision impaired * Severe cognitive impairment * Pending acute surgery or with a life prognosis of fewer than 6 months * The presence \[by self-report\] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine * Initiation or change of psychotropic medication dosage within the past 4 weeks * Received CBT for anxiety in last 3 months

Study design

Enrollment target: 95 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2022-02-02

Estimated completion: 2026-03-15

Last updated: 2025-03-14

Interventions

Behavioral: Daylight dCBT Application

Primary outcomes

• Generalized Anxiety Disorder Scale (GAD-7) (Week 10 (post-treatment))

Sponsor

Boston University Charles River Campus · other

Contacts & investigators

ContactMarie Parsons, Ph.D. · contact · mariepar@bu.edu · 617-353-9610

All locations (1)

Boston UniversityRecruiting

Boston, Massachusetts, United States

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