Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

项目摘要/摘要 糖尿病痛苦(DD)指的是由糖尿病引起的通常隐藏的情感负担、压力和担忧 管理高要求、进行性和慢性疾病，如1型糖尿病(T1D)。该病非常普遍， 大约42%的T1D成人表现出DD升高；与临床抑郁症不同；倾向于 慢性的，而不是间歇性的；并且与血糖控制不佳和有问题密切相关 自理行为。系统评价表明，对DD的有效干预措施的发展已经 受阻：大多数干预措施不是直接针对DD，而是提供各种形式的糖尿病 教育和疾病管理，很少有研究植根于推动 干预策略；研究设计很少允许直接比较不同方法以减少 相对较少的研究集中在T1D上，到目前为止还没有研究探索不同的DD方法 以直接最大限度地改善血糖控制的方式减少。为了解决这些问题，我们 建议对T1D成人进行三臂临床试验，使用理论支持的、基于证据的干预措施 测试通过情绪调节策略(TunedIn)直接针对DD的程序的附加值 以及统一的DD和疾病管理干预(FIXIT)，以减少DD并改善血糖控制， 相对于传统的教育/疾病管理干预(Streamline)。主要结果是 糖化血红蛋白。我们将探索将DD的变化与HbA1c随时间的变化联系起来的中介途径。这个 将评估选择性调节变量对干预效果的影响。干预成本和 利益相关者的意见将为传播和未来计划的实施提供信息。

PROJECT SUMMARY/ABSTRACT Diabetes distress (DD) refers to the often hidden emotional burdens, stresses, and worries that result from managing a demanding, progressive, and chronic disease like type 1 diabetes (T1D). DD is highly prevalent, with approximately 42% of T1D adults manifesting elevated DD; is distinct from clinical depression; tends to be chronic, rather than episodic; and has been significantly associated with poor glycemic control and problematic self-care behavior. Systematic reviews suggest the development of effective interventions for DD have been impeded by: the majority of interventions not targeting DD directly, instead delivering various forms of diabetes education and disease-management, few studies being grounded in a theoretical framework that drives an intervention strategy; study designs that rarely allow for direct comparison of different approaches to reduce DD; relatively few studies focused on T1D, and no study to date that has explored different approaches to DD reduction in ways that directly maximize improvements in glycemic control. To address these problems we propose a 3-arm clinical trial with T1D adults that uses theoretically supported, evidenced-based interventions to test the added value of a program that targets DD directly through emotion regulation strategies (TunedIn) and a unified DD and disease management intervention (FixIt) to reduce DD and improve glycemic control, relative to a traditional education/disease management intervention (StreamLine). The primary outcome is HbA1c. We will explore mediating pathways linking changes in DD with changes in HbA1c over time. The effect of selective moderating variables on intervention effectiveness will be assessed. Intervention costs and stakeholder input will inform dissemination and future program implementation.