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

Launched by BOSTON UNIVERSITY CHARLES RIVER CAMPUS · May 17, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new online therapy program called digital Cognitive Behavioral Therapy (dCBT) designed to help people with generalized anxiety disorder (GAD) who also have heart-related health issues. The aim is to see if this digital approach can effectively reduce anxiety and improve health behaviors for patients who may find it hard to attend in-person therapy due to their cardiovascular disease (CVD). The study will start with a small group to test how well the digital program is accepted and then expand to include about 90 participants who have recently experienced significant heart events, like a heart attack or stroke, and are currently dealing with anxiety.

To be eligible for this trial, participants need to be at least 18 years old and have had an acute heart event more than two months ago. They should also have a certain level of anxiety, measured by a scoring system. However, individuals who cannot use a digital device, have severe vision or cognitive impairments, or have certain mental health conditions will not be included. Those who join the trial can expect to be randomly assigned to either receive the digital therapy or be placed on a waitlist. This is a great opportunity for individuals looking for accessible support for their anxiety while managing their heart health.

Gender

ALL

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