Depression Treatment to Reduce the Excess Diabetes Risk of People with Depression and Prediabetes

项目摘要/摘要 糖尿病影响了3100万(12%)美国成年人，另有8200万(34%)成年人患有前驱糖尿病， 糖尿病的先兆。糖尿病的后果是严重的，包括心血管疾病、残疾、 和死亡。虽然这些统计数据强调了糖尿病预防的重要性，但目前的方法只有 部分效力。这显然需要确定新的初级预防目标和方法 对于糖尿病，抑郁症和抑郁症的治疗是这方面的有力候选者。20多年来， 证据表明，抑郁症是一种独立的、临床上重要的、健壮的、生物行为上可信的、 和糖尿病的可改变的危险因素。然而，研究还没有确定抑郁症的治疗方法 可以预防糖尿病前期患者的糖尿病发展。鉴于抑郁症仍在接受 在发生糖尿病预防的环境中(例如，初级保健)，关注有限，有一大群 糖尿病风险因素(抑郁)未被发现或治疗不足的患者。这一现状和 抑郁症到糖尿病科学的强大状态创造了对试验性随机对照试验的需求，以评估 抑郁症治疗作为一种新的糖尿病预防策略。因此，我们提出了初级保健的试点RCT 患有抑郁障碍和糖尿病前期的患者(50%)。患者将被随机分配到6个月的 EIMPACT-DM(干预)或主动控制(比较器)。EIMPACT-DM是我们的现代化协作 阶梯式护理干预包括(1)计算机化和电话认知行为疗法 抑郁和(2)选择包含在针对糖尿病风险优化的算法中的抗抑郁药物 还原。我们的初步数据证实了eIMPACT-DM的可行性和抗抑郁疗效。这个 积极控制包括抑郁症教育、症状监测和抑郁症的初级护理。我们的 主要目的是确定eIMPACT-DM在改善糖尿病风险标志物方面的初步疗效。 血红蛋白A1c(主要结果)和胰岛素抵抗(次要结果)。我们的探索目标是 探索躯体抑郁症状--即吞噬过多(食欲/体重增加)和/或 睡眠过多(睡眠增加)--缓和eIMPACT-DM对糖尿病风险标记物的影响。积极的一面 试点试验将通过以下方式为R01级RCT铺平道路：(1)生成关键的概念验证数据(eIMPACT- DM可以改善A1c)以支持最终试验的前提；(2)为 EIMPACT-DM关于糖尿病风险标记物的研究，以帮助证明未来电力分析的合理性；(3)确定潜在的 EIMPACT-DM疗效的重要调节剂，可能需要纳入最终试验。 最终，证明抑郁症治疗降低糖尿病风险将确定一个新的靶点 (抑郁症)用于糖尿病预防工作，它将为医疗保健提供者配备一种新的实用、 可扩展、可传播的干预(eIMPACT-DM)，以帮助降低大量高风险人群的糖尿病风险 有风险的病人。这些做法的改变应该转化为降低糖尿病的发病率、死亡率和成本。

PROJECT SUMMARY/ABSTRACT Diabetes affects 31 million (12%) U.S. adults, and another 82 million (34%) adults have prediabetes, a precursor to diabetes. The ramifications of diabetes are grave and include cardiovascular disease, disability, and death. While these statistics highlight the importance of diabetes prevention, current approaches have only partial effectiveness. This has created a clear need to identify new primary prevention targets and approaches for diabetes, and depression and depression treatment are strong candidates in this regard. Over 20 years of evidence indicates that depression is an independent, clinically important, robust, biobehaviorally plausible, and modifiable risk factor for diabetes. However, research has yet to determine whether depression treatment can prevent the development of diabetes in people with prediabetes. Given that depression is still receiving limited attention in settings where diabetes prevention occurs (e.g., primary care), there is a large cohort of patients with an underdetected or undertreated diabetes risk factor (depression). This status quo and the strong state of the depression-to-diabetes science create the need for a pilot RCT to evaluate the utility of depression treatment as a new diabetes prevention strategy. Thus, we propose a pilot RCT of 64 primary care patients (50% minority) with a depressive disorder and prediabetes. Patients will be randomized to 6 months of eIMPACT-DM (intervention) or Active Control (comparator). eIMPACT-DM is our modernized collaborative stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for diabetes risk reduction. Our preliminary data establish the feasibility and antidepressive efficacy of eIMPACT-DM. The Active Control consists of depression education, symptom monitoring, and primary care for depression. Our primary aim is to determine the preliminary efficacy of eIMPACT-DM in improving the diabetes risk markers of hemoglobin A1c (primary outcome) and insulin resistance (secondary outcome). Our exploratory aim is to explore whether somatic depressive symptoms – i.e., hyperphagia (increased appetite/weight) and/or hypersomnia (increased sleep) – moderate the effect of eIMPACT-DM on diabetes risk markers. A positive pilot trial would pave the way to an R01-level RCT by: (1) generating critical proof-of-concept data (eIMPACT- DM can improve A1c) to support the premise of the definitive trial; (2) providing preliminary effect sizes for eIMPACT-DM on diabetes risk markers to help justify future power analyses; (3) identifying a potentially important moderator of eIMPACT-DM efficacy that may need to be incorporated into the definitive trial. Ultimately, demonstrating that depression treatment reduces diabetes risk would identify a novel target (depression) for diabetes prevention efforts, and it would equip healthcare providers with a new practical, scalable, and disseminable intervention (eIMPACT-DM) to help lower diabetes risk for a large cohort of high- risk patients. These practice changes should translate into reduced diabetes morbidity, mortality, and costs.