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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Daylight dCBT Application
BehavioralParticipants will complete up to four modules of digital intervention delivered in a self-paced format.
Treatment groups
Trial outcomes
Primary outcomes
Generalized Anxiety Disorder Scale (GAD-7)
Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.
Secondary outcomes
Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)
Well validated 8-item measure of heart-related fear and worry. Scores can range from 0 to 32 with higher scores indicating greater cardiac anxiety.
Smoking History Questionnaire
Measure of the frequency and amount of recent cigarette use and motivation to quit.
International Physical Activities Questionnaire (IPAQ)
Well validated self-report measure of how many minutes a day and days a week an individual spends engaged in physical activity.
World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables
Number of servings per day of fruit and vegetables measured by relevant questions on the WHO STEPS Instrument.
Sponsors and contacts
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