Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
Recruiting · NCT04895995 · Interventional (participants receive a specific treatment) · Lead sponsor: Boston University Charles River Campus
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Boston University - Boston, Massachusetts, United States