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

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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Anxiety Disorders Cardiovascular Diseases Anxiety Health Behavior Behavioral: Daylight dCBT Application Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The allocation scheme below refers to Phase 2.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2022
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
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 Name: Daylight
No Intervention: Waitlist Control


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895995


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

Locations
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United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Marie Parsons, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
More Information
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Responsible Party: Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT04895995    
Other Study ID Numbers: 6035E
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Anxiety Disorders
Mental Disorders