Depression Treatment for Type 2 Diabetes Appalachians

阿巴拉契亚 2 型糖尿病的抑郁症治疗

• 批准号: 7083396
• 负责人: Mary K. de Groot
• 金额: $ 21.95万
• 依托单位: OHIO UNIVERSITY ATHENS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7083396
• 关键词: aerobic exercise; behavioral /social science research tag; cardiovascular disorder risk; clinical depression; clinical research; cognitive behavior therapy; combination therapy; comorbidity; health disparity; health services research tag; high density lipoproteins; human subject; human therapy evaluation; medically underserved population; noninsulin dependent diabetes mellitus; patient oriented research; rural health

DESCRIPTION (provided by applicant): The prevalence of type 2 diabetes (T2DM) continues to expand in epidemic proportions nationally and within the underserved rural Appalachian region. Low-income, at-risk populations, such as Appalachians, show increased risk for the development of type 2 diabetes (T2DM) and worsened outcomes. Depression is two times more likely in patients with T2DM than the general population. Depression rates among Appalachians with T2DM appear to be comparable to national means. Depression and diabetes is associated with worsened glycemic control and complications. Cognitive behavioral therapy (CBT) treatment has been shown to reduce depression and average blood sugars in T2DM patients. Aerobic exercise has been shown to be an efficacious treatment for major depression in patients without diabetes. To date, no studies have combined these treatments for patients with T2DM and depression. Advantages of this combined approach may include: extending depression remission through exercise maintenance; use of exercise as behavioral activation within the CBT framework; improvements in glycemic control; and potential for the reduction of cardiovascular risk factors such as HDL-C. The current study is a pilot and feasibility investigation of a community-based interdisciplinary approach to the treatment of depression in underserved rural Appalachian patients with T2DM, entitled Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise). The study is a single-group repeated measures design. The primary aims of the study are: 1) to assess the feasibility of recruitment, retention and adherence to this combined intervention program; 2) to assess the impact of the intervention on depression outcomes; 3) to assess the impact of the intervention on glycemic control; and 4) to assess the impact of the intervention on cardiovascular risk factors, specifically HDL-C. In Phase I, CBT and community-based exercise intervention protocols used in previous efficacy studies will be culturally-tailored for the Appalachian region. In Phase II, N=51 T2DM and depression participants will be recruited to receive 10 weekly sessions of CBT and 12 weeks of community-based aerobic exercise. Assessments will be conducted at baseline, post-intervention (POST) and 3-month follow-up (3MFU). Intention-to-treat analyses will be conducted to assess the feasibility of study recruitment, retention and the impact of intervention exposure on depressive symptoms, glycemic control, and changes in HDL-C as primary outcomes. Secondary outcomes of diabetes-specific quality of life and social support will also be examined. In addition, the feasibility of collecting cost - effectiveness data for use in the R18 trial will be assessed. Approximately 60% of participants are expected to be non-depressed at POST. Outcomes at POST and 3MFU are anticipated to show improvement over baseline. This study will inform the submission of an NIDDK R18 grant proposal for a multi-arm randomized clinical effectiveness trial of the culturally-tailored interdisciplinary depression intervention (usual care, CBT alone, exercise alone, combination therapy). The rationale for the R18 study mirrors the rationale for this R34 proposal. The study is anticipated to evaluate depression, glycemic control, and cardiovascular risk factor outcomes across 4 time points: baseline, POST, 6- and 12-month follow-up periods. Comparative effectiveness of the treatment arms as well as cost-effectiveness of treatment will be assessed.

描述（由申请人提供）： 2型糖尿病（T2DM）的患病率在全国范围内和服务不足的阿巴拉契亚地区内的流行比例继续扩展。低收入，高危人群，例如阿巴拉契亚人，表现出增加2型糖尿病（T2DM）的风险增加，并使结果恶化。 T2DM患者的抑郁症的可能性是普通人群的两倍。 T2DM的阿巴拉契亚人的抑郁率似乎与国家手段相当。抑郁症和糖尿病与血糖控制恶化和并发症有关。认知行为疗法（CBT）治疗已显示可减少T2DM患者的抑郁症和平均血糖。有氧运动已被证明是对没有糖尿病患者的重度抑郁症的有效治疗方法。迄今为止，尚无研究对T2DM和抑郁症患者的这些治疗。这种联合方法的优点可能包括：通过维持锻炼来扩展抑郁缓解；将运动用作CBT框架内的行为激活；血糖控制的改善；以及减少心血管危险因素（例如HDL-C）的潜力。当前的研究是对基于社区的跨学科方法的试验性和可行性调查，用于治疗未服务的阿巴拉契亚乡村T2DM患者的抑郁症，标题为“主动计划”（阿巴拉契亚人聚集在一起以增加重要的运动）。该研究是单组重复的措施设计。该研究的主要目的是：1）评估招聘，保留和遵守该合并干预计划的可行性； 2）评估干预对抑郁症预后的影响； 3）评估干预对血糖控制的影响； 4）评估干预对心血管危险因素的影响，特别是HDL-C。在第一阶段，在先前有效性研究中使用的基于CBT和社区的运动干预方案将在阿巴拉契亚地区进行文化规定。在第二阶段，n = 51 T2DM，将招募抑郁症参与者，以接受10个每周的CBT课程和12周的基于社区的有氧运动。评估将在基线，干预后（POST）和3个月随访（3MFU）进行。将进行意向性治疗分析，以评估研究募集，保留率以及干预暴露对抑郁症状，血糖控制以及HDL-C作为主要结果的变化的可行性。还将研究特定于糖尿病的生活质量和社会支持的次要结果。此外，将评估收集成本的可行性 - 在R18试验中使用的有效性数据。预计约60％的参与者在POST上不沮丧。预计Post和3MFU的结果将显示出比基线的改善。 这项研究将为NIDDK R18赠款提案的提交提供信息，用于对文化限制的跨学科抑郁干预措施进行多臂随机临床有效性试验（通常，仅CBT，单独进行CBT，单独运动，组合治疗）。 R18研究的理由反映了该R34提案的理由。预计该研究将评估4个时间点的抑郁症，血糖控制和心血管危险因素结果：基线，后，6个月和12个月的随访期。将评估治疗组的比较效率以及治疗的成本效益。