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

抑郁症治疗可降低抑郁症和糖尿病前期患者的过度糖尿病风险

• 批准号: 10092154
• 负责人: Jesse C Stewart
• 金额: $ 17.88万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10092154
• 关键词: Adult; Affect; Aftercare; Algorithms; Amputation; Antidepressive Agents; Attention; Blindness; Cardiovascular Diseases; Caring; Cessation of life; Clinical; Clinical Trials; Cognitive Therapy; Data; Depressed mood; Depressive disorder; Development; Diabetes Mellitus; Diabetes prevention; Effectiveness; Exhibits; Foundations; Future; Glycosylated hemoglobin A; Goals; Gold; Health Personnel; Hyperphagia; Hypersomnias; Insulin Resistance; Intervention; Kidney Diseases; Literature; Mental Depression; Minority; Modernization; Monitor; Morbidity - disease rate; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Patient Care; Patients; Pharmaceutical Preparations; Prediabetes syndrome; Prevention; Prevention strategy; Primary Health Care; Primary Prevention; Provider; Randomized; Request for Applications; Research; Risk; Risk Factors; Risk Marker; Risk Reduction; Science; Sleep; Subgroup; Symptoms; Telephone; Testing; Therapeutic Trials; Translating; Update; Weight; active control; base; biobehavior; cohort; computerized; cost; depressed patient; depression education; depressive symptoms; diabetes risk; disability; disorder prevention; effective intervention; efficacy evaluation; functional status; high risk; improved; increased appetite; modifiable risk; mortality; novel; pilot trial; power analysis; prevent; primary outcome; psychosocial; public health priorities; response; secondary outcome; statistics; tool

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.

项目摘要/摘要 糖尿病影响3100万（12％）美国成年人，另外8200万（34％）的成年人患有糖尿病，一个 糖尿病的前体。糖尿病的后果是严重的，包括心血管疾病，残疾， 和死亡。尽管这些统计数据强调了预防糖尿病的重要性，但目前的方法仅具有 部分有效性。这显然需要确定新的主要预防目标和方法 对于糖尿病，抑郁和抑郁症治疗在这方面是强大的候选人。超过20年 证据表明，抑郁症是一种独立的，临床上的重要，健壮的，生物行为合理的， 糖尿病的可修改风险因素。但是，研究尚未确定抑郁症是否治疗 可以防止糖尿病前患者的糖尿病发展。鉴于抑郁症仍在接受 在糖尿病预防的情况下（例如，初级保健），注意力有限 糖尿病危险因素（抑郁症）的患者（抑郁症）不足或缺乏。这个现状和 强烈的抑郁至糖尿病科学的状态使飞行员RCT需要评估效用 抑郁症治疗是一种新的糖尿病预防策略。那，我们提出了64个初级保健的飞行员RCT 患者（少数50％）患有抑郁症和糖尿病前期。患者将被随机分为6个月 EIMPACT-DM（干预）或主动控制（比较器）。 Eimpact-DM是我们的现代化协作 阶梯护理干预措施包括（1）计算机和电话认知行为疗法 抑郁症和（2）针对糖尿病风险优化的算法中包括的选择抗抑郁药 减少。我们的初步数据确定了Eimpact-DM的可行性和抗抑郁效率。 主动控制包括抑郁症教育，症状监测和抑郁症初级保健。我们的 主要目的是确定EIMPACT-DM在改善糖尿病风险标志方面的初步效率 血红蛋白A1C（主要结果）和胰岛素抵抗（次要结果）。我们的探索目的是 探索体细胞抑郁症状是否出现 - 即脾气暴躁（食欲增加/体重）和/或 高血压（睡眠增加） - 适度eimpact-DM对糖尿病风险标志的影响。积极 试验试验将为R01级RCT铺平道路：（1）生成关键的概念证明数据（Eimpact- DM可以改善A1C）来支持确定试验的前提； （2）提供初步效应大小 Eimpact-DM对糖尿病的风险标记有助于证明未来的功率分析； （3）识别潜在的 可能需要将EIMPACT-DM效率的重要主持人纳入确定性试验中。 最终，证明抑郁症治疗降低糖尿病风险将确定一个新的目标 （抑郁症）用于预防糖尿病的工作，它将为医疗保健提供者提供新的实用， 可扩展的和可融化的干预措施（EIMPACT-DM），可帮助降低糖尿病的风险 风险患者。这些实践变化应仅仅转化为减少的糖尿病，死亡率和成本。