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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895995
• Other study ID #: 6035E
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: March 2023
• Source: Boston University Charles River Campus
• Contact: Marie Parsons, Ph.D.
• Phone: 617-353-9610
• Email: mariepar[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cardiovascular Diseases
• Health Behavior

Intervention

Behavioral:
• Daylight dCBT Application
Participants will complete up to four modules of digital intervention delivered in a self-paced format.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	Smoking History Questionnaire	Measure of the frequency and amount of recent cigarette use and motivation to quit.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 6, and Week 10 (post-treatment)
Secondary	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.	Week 0, Week 3, Week 6
Secondary	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.	Week 10 (post-intervention)