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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

Primary Purpose

Anxiety Disorders, Cardiovascular Diseases, Anxiety

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Daylight dCBT Application

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Boston UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder

Waitlist Control

Arm Description

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder Scale (GAD-7)

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

Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)

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

Measure of the frequency and amount of recent cigarette use and motivation to quit.

International Physical Activities Questionnaire (IPAQ)

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

Number of servings per day of fruit and vegetables measured by relevant questions on the WHO STEPS Instrument.

Modified Morisky Scale

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

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)

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)

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)

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)

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)

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)

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

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.

Full Information

NCT ID

NCT04895995

First Posted

May 5, 2021

Last Updated

March 27, 2023

Sponsor

Boston University Charles River Campus

1. Study Identification

Unique Protocol Identification Number

NCT04895995

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

January 15, 2024 (Anticipated)

Study Completion Date

January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University Charles River Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders, Cardiovascular Diseases, Anxiety, Health Behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The allocation scheme below refers to Phase 2.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder

Arm Type

Experimental

Arm Title

Waitlist Control

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Daylight dCBT Application

Other Intervention Name(s)

Daylight

Intervention Description

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

Primary Outcome Measure Information:

Title

Generalized Anxiety Disorder Scale (GAD-7)

Description

Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.

Time Frame

Week 10 (post-treatment)

Secondary Outcome Measure Information:

Title

Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)

Description

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.

Time Frame