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

• ClinicalTrials.gov Identifier: NCT04895995
• Recruitment Status: Recruiting
• First Posted: May 21, 2021
• Last Update Posted: March 28, 2023
• Sponsor: Boston University Charles River Campus
• Information provided by (Responsible Party): Boston University Charles River Campus

Tracking Information

• First Submitted Date: May 5, 2021
• First Posted Date: May 21, 2021
• Last Update Posted Date: March 28, 2023
• Actual Study Start Date: February 2, 2022
• Estimated Primary Completion Date: January 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2021)

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.

Original Primary Outcome Measures (submitted: May 17, 2021)

• Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Week 6 (mechanism) ]
  Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.
• Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Week 10 (efficacy) ]
  Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.

Current Secondary Outcome Measures (submitted: May 5, 2022)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: May 17, 2021)

• Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear) [ Time Frame: Week 6 and Week 10 ]
  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.
• Smoking History Questionnaire [ Time Frame: Week 6 and Week 10 ]
  Measure of the frequency and amount of recent cigarette use and motivation to quit.
• International Physical Activities Questionnaire (IPAQ) [ Time Frame: Week 6 and Week 10 ]
  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 [ Time Frame: Week 6 and Week 10 ]
  Number of servings per day of fruit and vegetables measured by relevant questions on the WHO STEPS Instrument.
• Modified Morisky Scale [ Time Frame: Week 6 and Week 10 ]
  This measures will be used to determine medication adherence. Scores can range from 0 to 6 with higher scores indicating greater adherence.
• Center for Epidemiological Studies Depression Scale 10 Item Version [ Time Frame: Week 6 and Week 10 ]
  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) [ Time Frame: Week 6 and Week 10 ]
  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.
• Short Form Health Survey (SF-12) [ Time Frame: Week 6 and Week 10 ]
  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.
• Anxiety Sensitivity Inventory (ASI-3) [ Time Frame: Week 6 and Week 10 ]
  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) [ Time Frame: Week 6 and Week 10 ]
  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) [ Time Frame: Week 6 and Week 10 ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The allocation scheme below refers to Phase 2.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Anxiety Disorders
• Cardiovascular Diseases
• Anxiety
• Health Behavior

Intervention

Behavioral: Daylight dCBT Application

Participants will complete up to four modules of digital intervention delivered in a self-paced format.

Other Name: Daylight

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 5, 2022): 95
• Original Estimated Enrollment (submitted: May 17, 2021): 90
• Estimated Study Completion Date: January 15, 2024
• Estimated Primary Completion Date: January 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04895995
• Other Study ID Numbers: 6035E
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Boston University Charles River Campus
• Original Responsible Party: Same as current
• Current Study Sponsor: Boston University Charles River Campus
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boston University Charles River Campus
• Verification Date: March 2023