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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2026-03-15

Brief Summary

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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).

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Detailed Description

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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. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, 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). Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).

Conditions

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Anxiety Disorders Cardiovascular Diseases Anxiety Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The allocation scheme below refers to Phase 2.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder

Group Type EXPERIMENTAL

Daylight dCBT Application

Intervention Type BEHAVIORAL

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

Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Daylight dCBT Application

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Daylight

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No