RecruitingNot ApplicableNCT04895995

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


Sponsor

Boston University Charles River Campus

Enrollment

95 participants

Start Date

Feb 2, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital cognitive behavioral therapy (CBT) program specifically designed to treat generalized anxiety in people who have had a cardiovascular event (like a heart attack or stroke). Researchers want to know if an app-based CBT program is feasible and effective for this population. **You may be eligible if...** - You are 18 or older - You have experienced a major cardiovascular event (heart attack, stroke or TIA, cardiac arrest, unstable angina, or hospitalization for heart failure) - It has been more than 2 months since your cardiac event (you are in the recovery phase) - You have significant anxiety symptoms (scoring 10 or higher on the GAD-7 anxiety screening) - You have access to a digital device (phone, tablet, or computer) **You may NOT be eligible if...** - You do not speak or read English - You have severe vision impairment or severe cognitive impairment - You have schizophrenia, psychosis, bipolar disorder, seizure disorder, or active substance use disorder - You started or changed a psychiatric medication in the last 4 weeks - You received CBT for anxiety in the last 3 months - You have pending acute surgery or a life expectancy under 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDaylight dCBT Application

Participants will complete up to four modules of digital intervention delivered in a self-paced format.


Locations(1)

Boston University

Boston, Massachusetts, United States

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NCT04895995


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