RECRUITING

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 Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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).

Official Title

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

Quick Facts

Study Start:2022-02-02
Study Completion:2024-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04895995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7
  3. * Age 18 or older.
  4. * Individuals must be in the post-acute phase of their CVD; this is operationalized as \> 2 months post an acute cardiac event.
  1. * Non-English speaker/literate
  2. * No access to a digital device
  3. * Severely vision impaired
  4. * Severe cognitive impairment
  5. * Pending acute surgery or with a life prognosis of fewer than 6 months
  6. * The presence \[by self-report\] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
  7. * Initiation or change of psychotropic medication dosage within the past 4 weeks
  8. * Received CBT for anxiety in last 3 months

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Boston University
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02
Study Completion Date2024-01-15

Study Record Updates

Study Start Date2022-02-02
Study Completion Date2024-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Anxiety Disorders
  • Cardiovascular Diseases
  • Anxiety
  • Health Behavior