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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Anxiety; Health Behavior; Anxiety Disorders
• Interventions: Behavioral: Daylight dCBT Application

• Registration Number: NCT04895995
• Lead Sponsor: Boston University Charles River Campus

Brief Summary

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).

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 Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-21
• Study Start: 2022-02-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder	Daylight dCBT Application	-

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder Scale (GAD-7)	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.

Secondary Outcome Measures

Name	Time	Method
Smoking History Questionnaire	Week 0, Week 6, and Week 10 (post-treatment)	Measure of the frequency and amount of recent cigarette use and motivation to quit.
International Physical Activities Questionnaire (IPAQ)	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.
World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables	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.
Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)	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.
Modified Morisky Scale	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.
Short Form Health Survey (SF-12)	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.
Center for Epidemiological Studies Depression Scale 10 Item Version	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.
Sleep Condition Indicator (SCI-8)	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.
Anxiety Sensitivity Inventory (ASI-3)	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.
Penn State Worry Questionnaire (PSWQ)	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.
Shame Inventory-Part 1 (SI-P1)	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.
Generalized Anxiety Disorder Scale (GAD-7)	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.
Resolution of Clinical GAD	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.

Trial Locations

Locations (1)

Boston University; 🇺🇸 Boston, Massachusetts, United States