Digital CBT for Anxiety in Cardiovascular Disease

This study is looking at a digital cognitive behavioral therapy (dCBT) called "Daylight dCBT Application" for people with generalized anxiety disorder (GAD) and cardiovascular disease (CVD). The goal is to see if this digital tool can help reduce anxiety symptoms in this group, as it can be hard for them to attend in-person therapy. Researchers will measure anxiety levels using the Generalized Anxiety Disorder Scale (GAD-7) after 10 weeks of treatment. The study plans to enroll 95 participants who are 18 or older, have experienced an acute CVD event (like a heart attack or stroke), and have significant GAD symptoms. The current recruitment status is unclear.

Study design
This interventional study will first assess the acceptability of the digital intervention in 5 participants, then randomize 90 individuals with acute CVD and GAD symptoms to either the Daylight dCBT Application or a waitlist control group.
What's involved
Participants will complete up to four modules of the digital intervention at their own pace. Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).
Compensation
Not stated in the trial record.
Follow-up
Anxiety levels will be measured at Week 10 (post-treatment).

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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

Recruiting
NAAges 18+InterventionalTreatment
Boston University Charles River Campus
~95 participants
Updated 2025-03-14 on ClinicalTrials.gov
What's tested:Daylight dCBT Application

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Generalized Anxiety Disorder Scale (GAD-7)
Measured over Week 10 (post-treatment)
Anxiety Disorders
Cardiovascular Diseases
Anxiety
Health Behavior
1 sites across 1 states
Massachusetts1

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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
  • Generalized Anxiety Disorder Scale (GAD-7)Week 10 (post-treatment)

    Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.