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

项目总结/摘要 糖尿病困扰（DD）是指经常隐藏的情感负担，压力和担忧， 1型糖尿病（T1 D）是一种慢性、渐进性疾病。DD非常普遍， 大约42%的T1 D成人表现出DD升高;与临床抑郁症不同;倾向于 慢性的，而不是偶发的;并且与血糖控制不良和有问题的 自我照顾行为。系统性综述表明，对DD的有效干预措施的发展已经 阻碍：大多数干预措施不直接针对DD，而是提供各种形式的糖尿病 教育和疾病管理，很少有研究是建立在一个理论框架，推动一个 干预策略;研究设计很少允许直接比较不同的方法，以减少 DD;关注T1 D的研究相对较少，迄今为止还没有研究探索DD的不同方法 减少的方式，直接最大限度地改善血糖控制。为了解决这些问题，我们 建议在T1 D成人患者中开展一项3组临床试验，使用理论支持的循证干预措施 测试通过情绪调节策略（TunedIn）直接针对DD的计划的附加值 和统一的DD和疾病管理干预（FixIt），以减少DD和改善血糖控制， 相对于传统的教育/疾病管理干预（流线）。主要结局是 HbA1c我们将探索随着时间的推移将DD变化与HbA 1c变化联系起来的介导途径。的 将评估选择性调节变量对干预效果的影响。干预费用和 利益攸关方的投入将为传播和今后的方案执行提供信息。

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.