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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University Charles River Campus

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-English speaker/literate

No access to a digital device

Severely vision impaired

Severe cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Daylight dCBT Application

    Behavioral

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

Treatment groups

95 Participants
are divided into 2 treatment groups
Group A: Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety DisorderExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Generalized Anxiety Disorder Scale (GAD-7)

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

Time frame
Week 10 (post-treatment)

Secondary outcomes

1

Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)

Well validated 8-item measure of heart-related fear and worry. Scores can range from 0 to 32 with higher scores indicating greater cardiac anxiety.

Time frame
Week 0, Week 6, and Week 10 (post-treatment)
2

Smoking History Questionnaire

Measure of the frequency and amount of recent cigarette use and motivation to quit.

Time frame
Week 0, Week 6, and Week 10 (post-treatment)
3

International Physical Activities Questionnaire (IPAQ)

Well validated self-report measure of how many minutes a day and days a week an individual spends engaged in physical activity.

Time frame
Week 0, Week 6, and Week 10 (post-treatment)
4

World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables

Number of servings per day of fruit and vegetables measured by relevant questions on the WHO STEPS Instrument.

Time frame
Week 0, Week 6, and Week 10 (post-treatment)

Other outcomes

Sponsors and contacts

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