Status:

RECRUITING

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

Lead Sponsor:

Boston University Charles River Campus

Conditions:

Anxiety Disorders

Cardiovascular Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

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 barri...

Detailed Description

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 barri...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 2 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 15 2026

Estimated Enrollment :

95 Patients enrolled

Trial Details

Trial ID

NCT04895995

Start Date

February 2 2022

End Date

March 15 2026

Last Update

March 14 2025

Active Locations (1)

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1

Boston University

Boston, Massachusetts, United States, 02215