Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Generalized Anxiety Disorder Scale (GAD-7)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder
干预措施: Daylight dCBT Application (Behavioral)
Waitlist Control
结局指标
主要结局
Generalized Anxiety Disorder Scale (GAD-7)
时间窗: 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.
次要结局
- Smoking History Questionnaire(Week 0, Week 6, and Week 10 (post-treatment))
- International Physical Activities Questionnaire (IPAQ)(Week 0, Week 6, and Week 10 (post-treatment))
- World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables(Week 0, Week 6, and Week 10 (post-treatment))
- Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)(Week 0, Week 6, and Week 10 (post-treatment))
- Modified Morisky Scale(Week 0, Week 6, and Week 10 (post-treatment))
- Short Form Health Survey (SF-12)(Week 0, Week 6, and Week 10 (post-treatment))
- Center for Epidemiological Studies Depression Scale 10 Item Version(Week 0, Week 6, and Week 10 (post-treatment))
- Sleep Condition Indicator (SCI-8)(Week 0, Week 6, and Week 10 (post-treatment))
- Anxiety Sensitivity Inventory (ASI-3)(Week 0, Week 6, and Week 10 (post-treatment))
- Penn State Worry Questionnaire (PSWQ)(Week 0, Week 6, and Week 10 (post-treatment))
- Shame Inventory-Part 1 (SI-P1)(Week 0, Week 6, and Week 10 (post-treatment))
- Generalized Anxiety Disorder Scale (GAD-7)(Week 0, Week 3, Week 6)
- Resolution of Clinical GAD(Week 10 (post-intervention))