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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University Charles River Campus

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

Non-English speaker/literate

No access to a digital device

Severely vision impaired

Severe cognitive impairment

Trial design

Treatments tested in this trial

  • Daylight dCBT Application

Treatment groups

95 Participants
are divided into 2 treatment groups