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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University Charles River Campus
Study ID
NCT04895995
Status
Recruiting
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Conditions

  • Anxiety
  • Anxiety Disorders
  • Cardiovascular Diseases
  • Health Behavior

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daylight dCBT Application — BEHAVIORAL
    Participants will complete up to four modules of digital intervention delivered in a self-paced format.

Study Details

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).

Key Dates

Start date
Feb 2, 2022
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Mar 15, 2026

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder
  • No Intervention: Waitlist Control

Primary Outcome Measure

Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Week 10 (post-treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston UniversityBostonMassachusetts02215
Marie Parsons, PhD

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By research site
Boston University· Boston, MA

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