Digital cognitive behavioral therapy for anxiety in heart disease patients
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
This study is testing whether a digital therapy program can help people with anxiety who have had heart problems feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04895995 on ClinicalTrials.gov |
What this trial studies
This pilot project aims to assess the feasibility and efficacy of a digital cognitive behavioral therapy (dCBT) intervention for individuals with generalized anxiety disorder (GAD) who have experienced acute cardiovascular disease (CVD) events. The study will begin with an open assessment of the digital intervention's acceptability, followed by the recruitment and randomization of 90 participants to either the dCBT group or a waitlist control group. Participants will be evaluated at baseline and at three subsequent time points to measure the intervention's impact on anxiety symptoms and health behaviors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who have experienced an acute cardiovascular event and exhibit clinical levels of generalized anxiety symptoms.
Not a fit: Patients who are non-English speakers, lack access to digital devices, or have severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide accessible mental health support for patients with cardiovascular disease, improving their anxiety management and overall health outcomes.
How similar studies have performed: Previous studies have shown significant benefits of digital cognitive behavioral therapy for anxiety, indicating a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston University — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Marie Parsons, Ph.D.
- Email: mariepar@bu.edu
- Phone: 617-353-9610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.