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.

项目总结/摘要 糖尿病影响3100万（12%）美国成年人，另有8200万（34%）成年人患有前驱糖尿病， 糖尿病的前兆糖尿病的后果是严重的，包括心血管疾病，残疾， 与死虽然这些统计数据突出了糖尿病预防的重要性，但目前的方法仅 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，抑郁症和抑郁症治疗是这方面的强有力的候选者。逾20年 有证据表明抑郁症是一种独立的、临床上重要的、稳健的、生物行为上合理的， 和可改变的糖尿病风险因素。然而，研究还没有确定抑郁症治疗是否 可以预防糖尿病前期患者的糖尿病发展。考虑到抑郁症仍在接受 在发生糖尿病预防的环境中注意力有限（例如，初级保健），有一个大的队列， 糖尿病风险因素（抑郁症）检测不足或治疗不足的患者。这种现状和 抑郁症-糖尿病科学的强大状态需要一个试点RCT来评估 抑郁症治疗作为糖尿病预防的新策略。因此，我们提出了一个试点随机对照试验64初级保健 患有抑郁症和糖尿病前期的患者（50%为少数）。患者将被随机分配至6个月的 eIMPACT-DM（干预）或活性对照（对照）。eIMPACT-DM是我们现代化的协作 阶梯式护理干预，包括（1）计算机化和电话认知行为治疗， 抑郁症和（2）选择抗抑郁药物，包括在糖尿病风险优化算法中 还原我们的初步数据确立了eIMPACT-DM的可行性和抗抑郁疗效。的 主动控制包括抑郁症教育、症状监测和抑郁症初级护理。我们 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A1 c（主要结局）和胰岛素抵抗（次要结局）。我们的探索目标是 探索躯体抑郁症状-即，食欲亢进（食欲/体重增加）和/或 嗜睡（睡眠增加）-缓解eIMPACT-DM对糖尿病风险标志物的影响。积极的 试点试验将通过以下方式为R 01级RCT铺平道路：（1）生成关键概念验证数据（eIMPACT- DM可以改善A1 c），以支持确定性试验的前提;（2）提供初步的效应量， eIMPACT-DM对糖尿病风险标志物的影响，以帮助证明未来的功效分析;（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，证明抑郁症治疗可以降低糖尿病风险将确定一个新的目标 （抑郁症）的糖尿病预防工作，它将配备一个新的实用， 可扩展和可传播的干预（eIMPACT-DM），以帮助降低糖尿病风险的一个大队列的高， 风险患者。这些做法的改变应转化为降低糖尿病发病率，死亡率和成本。