Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daylight dCBT Application.
- Who it may be relevant to
- Registry conditions: Anxiety Disorders, Cardiovascular Diseases, Anxiety, Health Behavior. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Behavioral Daylight dCBT Application
Participants will complete up to four modules of digital intervention delivered in a self-paced format.
Primary outcome measures
- Generalized Anxiety Disorder Scale (GAD-7) [Time frame: Week 10 (post-treatment)]
Secondary outcome measures (12)
- Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Smoking History Questionnaire [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- International Physical Activities Questionnaire (IPAQ) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Modified Morisky Scale [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Center for Epidemiological Studies Depression Scale 10 Item Version [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Sleep Condition Indicator (SCI-8) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Short Form Health Survey (SF-12) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Anxiety Sensitivity Inventory (ASI-3) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Penn State Worry Questionnaire (PSWQ) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Shame Inventory-Part 1 (SI-P1) [Time frame: Week 0, Week 6, and Week 10 (post-treatment)]
- Generalized Anxiety Disorder Scale (GAD-7) [Time frame: Week 0, Week 3, Week 6]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston University — Boston
Publications
- Parsons EM, Hiserodt M, Otto MW. Initial assessment of the feasibility and efficacy of a scalable digital CBT for generalized anxiety and associated health behaviors in a cardiovascular disease population. Contemp Clin Trials. 2023 Jan;124:107018. doi: 10.1016/j.cct.2022.107018. Epub 2022 Nov 19. PMID 36414206
Identifiers
NCT: NCT04895995 · 6035E