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

Purpose

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).

Conditions

  • Anxiety Disorders
  • Cardiovascular Diseases
  • Anxiety
  • Health Behavior

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The allocation scheme below refers to Phase 2.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder
  • Behavioral: Daylight dCBT Application
    Participants will complete up to four modules of digital intervention delivered in a self-paced format.
    Other names:
    • Daylight
No Intervention
Waitlist Control

Recruiting Locations

Boston University
Boston, Massachusetts 02215
Contact:
Marie Parsons, PhD

More Details

Status
Recruiting
Sponsor
Boston University Charles River Campus

Study Contact

Marie Parsons, Ph.D.
617-353-9610
mariepar@bu.edu

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 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).