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

Key facts

Who runs it
Boston University Charles River Campus
Where
Boston, United StatesSee the site
Trial code
Status
Completed
People taking part
30 people enrolled
Started
2 Feb 2022
Ended
13 Jan 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Daylight dCBT Application
Record updated
2 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Pending acute surgery or with a life prognosis of fewer than 6 months
  • Initiation or change of psychotropic medication dosage within the past 4 weeks
  • Received CBT for anxiety in last 3 months
  • Severe cognitive impairment
  • The presence [by self-report] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
  • Non-English speaker/literate
  • No access to a digital device
  • Severely vision impaired

Where in United States

  • Boston UniversityBoston, United States

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety DisorderTreatment being tested

    Treatment: Daylight dCBT Application

  • Waitlist ControlNo study treatment, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
2 September 2026