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) 的患病率在全国和医疗服务不足的阿巴拉契亚农村地区继续呈流行趋势。低收入高危人群，如阿巴拉契亚山脉，患 2 型糖尿病 (T2DM) 的风险增加，结果恶化。 T2DM 患者患抑郁症的可能性是普通人群的两倍。阿巴拉契亚地区 2 型糖尿病患者的抑郁率似乎与全国平均水平相当。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）已被证明可以降低 T2DM 患者的抑郁症和平均血糖。有氧运动已被证明是治疗非糖尿病患者重度抑郁症的有效方法。迄今为止，还没有研究将这些治疗方法联合起来治疗 T2DM 和抑郁症患者。这种组合方法的优点可能包括： 通过维持运动来延长抑郁症的缓解；在 CBT 框架内使用锻炼作为行为激活；改善血糖控制；以及降低 HDL-C 等心血管危险因素的潜力。目前的研究是一项基于社区的跨学科方法的试点和可行性调查，用于治疗服务不足的阿巴拉契亚农村 T2DM 患者的抑郁症，名为“ACTIVE 计划”（阿巴拉契亚人齐心协力增加重要锻炼）。该研究是单组重复测量设计。该研究的主要目的是：1）评估招募、保留和遵守这一联合干预计划的可行性； 2）评估干预措施对抑郁结果的影响； 3）评估干预措施对血糖控制的影响； 4) 评估干预措施对心血管危险因素（特别是高密度脂蛋白胆固醇）的影响。在第一阶段，先前功效研究中使用的 CBT 和基于社区的运动干预方案将针对阿巴拉契亚地区的文化进行定制。在第二阶段，将招募 N=51 名 T2DM 和抑郁症参与者，接受每周 10 次 CBT 课程和 12 周的社区有氧运动。评估将在基线、干预后 (POST) 和 3 个月随访 (3MFU) 时进行。将进行意向治疗分析，以评估研究招募、保留的可行性以及作为主要结局的干预措施对抑郁症状、血糖控制和 HDL-C 变化的影响。还将检查糖尿病特定的生活质量和社会支持的次要结果。此外，还将评估收集用于 R18 试验的成本效益数据的可行性。预计大约 60% 的参与者在 POST 时不会感到抑郁。 POST 和 3MFU 的结果预计将比基线有所改善。 这项研究将为提交 NIDDK R18 拨款提案提供信息，该提案用于针对文化定制的跨学科抑郁症干预措施（常规护理、单独 CBT、单独运动、联合治疗）的多臂随机临床有效性试验。 R18 研究的基本原理反映了 R34 提案的基本原理。该研究预计将评估 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、术后、6 个月和 12 个月的随访期。将评估治疗组的比较效果以及治疗的成本效益。