Multisite feasibility of BA-HD: An integrated depression and behavioral risk factor reduction coaching program following acute coronary syndrome

BA-HD 的多地点可行性：急性冠脉综合征后的综合抑郁症和行为危险因素减少辅导计划

• 批准号: 10680636
• 负责人: Andrew M Busch
• 金额: $ 35.43万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10680636
• 关键词: Adherence; Adult; Affect; American Heart Association; Behavior Therapy; Behavioral; Behavioral trial; Clinical; Counseling; Data; Depressed mood; Development; Diet; Disease; Feasibility Studies; Feedback; Goals; Health; Health behavior; Health behavior change; Health system; Hospitalization; Hospitals; Individual; Intervention; Interview; Life; Link; Maintenance; Manuals; Measurement; Medical; Mental Depression; Mental Health Services; Midwestern United States; Moods; Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Outcome; Patients; Pharmaceutical Preparations; Physical activity; Population; Positive Reinforcements; Preparation; Procedures; Protocols documentation; Provider; Public Health; Randomized; Recommendation; Recovery; Recurrence; Relapse; Research; Research Design; Risk; Risk Factors; Risk Reduction; Sampling; Site; Smoke; Smoking; Source; Standardization; Telephone; Testing; Training; Unhealthy Diet; United States; Unstable angina; Work; acceptability and feasibility; acute coronary syndrome; arm; cardiovascular health; cardiovascular risk factor; clinically significant; comparison intervention; cost; design; diet and exercise; efficacy evaluation; efficacy trial; feasibility trial; follow-up; health assessment; improved; medically underserved; medication compliance; model development; mortality; mortality risk; novel; novel strategies; participant retention; pilot test; prevent; prognostic; programs; prospective; recruit; rural underserved; safety net; secondary outcome; smoking abstinence; smoking cessation; therapy development; treatment as usual; usual care arm

PROJECT ABSTRACT Acute coronary syndrome (ACS) is an urgent public health issue which contributes to over one million hospitalizations annually. Depression undermines optimal recovery following ACS, often at least partially through interference with health behaviors. Post-ACS patients with depression smoke more, adhere to medications less often, are less physically active, and have poorer diet than post-ACS patients without depression. This reduced adherence to recommended health behaviors, in turn, worsens cardiovascular health and increases risk of additional morbidity and mortality. Our team developed Behavioral Activation for Health and Depression (BA-HD) which is a behavioral activation-based intervention that integrates treatment for depression and multiple health behavior change post-ACS. The overarching goal of this R34 application is to pilot BA-HD across three distinct regions (Northeast, Midwest, and Southeast) in preparation for a subsequent fully powered multisite randomized controlled efficacy trial. Specifically, the research team will conduct a multisite pilot randomized controlled feasibility trial of BA-HD comparing the intervention to an Enhanced Usual Care (EUC) control group. This trial will accomplish two aims: First, we will examine study feasibility (e.g., recruitment, treatment engagement, retention) and acceptability of both study procedures and the BA-HD treatment. Second, we will examine the preliminary efficacy of BA-HD to improve (1) depressed mood and (2) cardiovascular health assessed via the American Heart Association’s Life’s Simple 7 Total Score. Findings from the proposed research are necessary to finalize study design in preparation for a subsequent fully powered trial to evaluate the efficacy of BA-HD to improve cardiovascular health and depression

项目摘要 急性冠状动脉综合征（ACS）是一个紧迫的公共卫生问题， 每年住院。抑郁症会破坏ACS后的最佳恢复，通常至少部分 通过干预健康行为。ACS后抑郁患者吸烟多，坚持 药物治疗频率较低，身体活动较少，饮食比ACS后患者更差， 萧条这减少了对推荐健康行为的坚持，反过来又损害了心血管健康 并增加了额外发病率和死亡率的风险。我们的团队开发了健康行为激活 和抑郁症（BA-HD），这是一种基于行为激活的干预， ACS后抑郁症和多种健康行为发生变化。此R34应用程序的首要目标是 在三个不同的地区（东北部、中西部和东南部）进行BA-HD试点，为随后的 完全把握度的多中心随机对照疗效试验。具体而言，研究小组将进行一项 BA-HD的多中心初步随机对照可行性试验，比较干预与增强型腹膜透析 护理（EUC）对照组。这项试验将实现两个目标：首先，我们将审查研究的可行性（例如， 招募、治疗参与、保留）以及研究程序和BA-HD的可接受性 治疗其次，我们将检查BA-HD改善（1）抑郁情绪和（2） 心血管健康通过美国心脏协会的生活简单7总评分评估。结果 从拟议的研究是必要的，以最终确定研究设计，为随后的全面准备 一项评估BA-HD改善心血管健康和抑郁症疗效的把握度试验