NCT04895995 Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
| NCT ID | NCT04895995 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University Charles River Campus |
| Condition | Anxiety Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2022-02-02 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2022-02-02 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04895995 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04895995 currently recruiting?
Yes, NCT04895995 is actively recruiting participants. Contact the research team at mariepar@bu.edu for enrollment information.
Where is the NCT04895995 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04895995 clinical trial?
NCT04895995 is sponsored by Boston University Charles River Campus. The trial plans to enroll 95 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.