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

March 13, 2025 updated by: Boston University Charles River Campus
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marie Parsons, Ph.D.
  • Phone Number: 617-353-9610
  • Email: mariepar@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Boston University
        • Contact:
          • Marie Parsons, PhD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Waitlist Control
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: Week 10 (post-treatment)
Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.
Week 10 (post-treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
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.
Week 0, Week 6, and Week 10 (post-treatment)
Smoking History Questionnaire
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
Measure of the frequency and amount of recent cigarette use and motivation to quit.
Week 0, Week 6, and Week 10 (post-treatment)
International Physical Activities Questionnaire (IPAQ)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
Well validated self-report measure of how many minutes a day and days a week an individual spends engaged in physical activity.
Week 0, Week 6, and Week 10 (post-treatment)
World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
Number of servings per day of fruit and vegetables measured by relevant questions on the WHO STEPS Instrument.
Week 0, Week 6, and Week 10 (post-treatment)
Modified Morisky Scale
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
This measures will be used to determine medication adherence. Scores can range from 0 to 6 with higher scores indicating greater adherence.
Week 0, Week 6, and Week 10 (post-treatment)
Center for Epidemiological Studies Depression Scale 10 Item Version
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
Validated 10-item self-report measure of depression symptoms. Scores can range from 0 to 30 with higher scores indicating greater depression.
Week 0, Week 6, and Week 10 (post-treatment)
Sleep Condition Indicator (SCI-8)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
This 8-item self-report measure is widely used to characterize sleep quality. Scores can range from 0 to 32 with higher scores indicating greater sleep difficulties.
Week 0, Week 6, and Week 10 (post-treatment)
Short Form Health Survey (SF-12)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
This 12-item measure is widely used to evaluate quality of life related to both physical and mental health with cardiac patients. Scores for each subscale range from 0 to 100 with higher scores indicating greater physical and mental health.
Week 0, Week 6, and Week 10 (post-treatment)
Anxiety Sensitivity Inventory (ASI-3)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
This 16-item self-report measures evaluates individuals' tendency to fear and perceive anxiety-related sensations as harmful. Scores can range from 0 to 72 with higher scores indicating greater anxiety sensitivity.
Week 0, Week 6, and Week 10 (post-treatment)
Penn State Worry Questionnaire (PSWQ)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
The PSWQ is the most commonly used self-report measure of worry in research on CBT and dCBT. Scores can range from 16 to 80 with higher scores indicating greater worry.
Week 0, Week 6, and Week 10 (post-treatment)
Shame Inventory-Part 1 (SI-P1)
Time Frame: Week 0, Week 6, and Week 10 (post-treatment)
This 3-item self-report measures assesses the frequency, intensity, and adverse effects of shame related to physical and mental health. Scores can range from 0 to 12 with higher scores indicating greater shame.
Week 0, Week 6, and Week 10 (post-treatment)
Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: Week 0, Week 3, Week 6
Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.
Week 0, Week 3, Week 6
Resolution of Clinical GAD
Time Frame: Week 10 (post-intervention)
The proportion of patients no longer meeting GAD-7 clinical severity, operationalized as a score of less than 10 at the 10 week evaluation. Scoring will be the same as described for the GAD-7 above.
Week 10 (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6035E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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