Clinical trial NCT04895995: 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
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Cardiovascular Diseases
Anxiety
Health Behavior
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The allocation scheme below refers to Phase 2.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Week 10 (post-treatment)
Secondary outcomes:
measure: Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Smoking History Questionnaire
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: International Physical Activities Questionnaire (IPAQ)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Modified Morisky Scale
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Center for Epidemiological Studies Depression Scale 10 Item Version
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Sleep Condition Indicator (SCI-8)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Short Form Health Survey (SF-12)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Anxiety Sensitivity Inventory (ASI-3)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Shame Inventory-Part 1 (SI-P1)
timeFrame: Week 0, Week 6, and Week 10 (post-treatment)
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Week 0, Week 3, Week 6
measure: Resolution of Clinical GAD
timeFrame: Week 10 (post-intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References: