Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

活动 II 计划：2 型糖尿病的行为抑郁治疗

基本信息

批准号：
8324571
负责人：
Mary K. de Groot
金额：
$ 62.88万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-08-01 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8324571
关键词：
Address Adherence Adopted Adoption Adult Advertisements Affect Aftercare Antidepressive Agents Appalachian Region Behavior Therapy Behavioral Blood Glucose Blood Pressure Caring Clinical Trials Design Cognitive Cognitive Therapy Communities Community Healthcare Complications of Diabetes Mellitus Coronary heart disease County Development Diabetes Mellitus Dietary Intervention Effectiveness Eligibility Determination Epidemic Exercise Face Funding Glycosylated hemoglobin A Health Healthcare Healthcare Systems Incidence Indiana Individual Intention Intervention Low-Density Lipoproteins Measures Mental Depression Mental Health Modality Modeling Moods Non-Insulin-Dependent Diabetes Mellitus Ohio Outcome Participant Patients Pharmaceutical Preparations Physicians Pilot Projects Population Poverty Prevalence Principal Investigator Psychiatric Hospitals Quality of life Randomized Randomized Controlled Trials Recruitment Activity Relative (related person)Resources Rest Risk Rural Rural Community Sample Size Sampling Site Testing Time Transportation Treatment Cost Universities West Virginia Work arm base blood lipid cardiovascular risk factor community setting comparative comparative effectiveness comparative treatment cost cost effectiveness depressive symptoms design diabetes education fasting glucose follow-up functional disability glycemic control group intervention improved innovation medical schools meetings mortality nutrition education primary outcome programs rural area secondary outcome treatment as usual treatment program underserved rural area

项目摘要

DESCRIPTION (provided by applicant): The prevalence of type 2 diabetes (T2DM) has reached epidemic proportions nationally and within underserved rural areas . Economically impoverished populations show increased risk for the development of T2DM and worsened outcomes. Rural residents are disproportionately affected by poverty and barriers to health care that contribute to these outcomes. Depression (MDD) affects 1 in 4 patients with diabetes. Depression is associated with worsened blood glucose levels and diabetes complications. Depression and T2DM also result in significant costs including: financial demands on health care systems, decreases to adherence and quality of life, increased functional disability and early mortality due to a variety of causes. Cognitive behavioral therapy (CBT) and exercise have the capacity to work synergistically as a win-win strategy to improve both T2DM and MDD outcomes while reducing barriers to care endemic to rural regions. Our group conducted a successful pilot study (R34DK071545) entitled, Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise) to test the feasibility of recruitment, retention and change in outcomes using CBT and community-based exercise among rural Appalachian adults with T2DM. We observed improvements in diabetes, MDD, and LDL-C outcomes at post-treatment and 3-month follow-up (3MFU) compared to baseline. A randomized controlled trial (RCT) of Program ACTIVE is proposed to test whether the combination behavioral treatment results in greater improvements in MDD and T2DM outcomes compared to exercise alone, CBT alone and usual care. The study will utilize a 2X2 factorial repeated measures RCT design in which participants will be assessed at baseline, immediately following the intervention (POST), 6- and 12-month follow-up time points. Intervention materials developed in the previous pilot study will be used. Two intervention sites serving rural central Appalachian counties of Ohio and West Virginia will be coordinated by the PI at Indiana University. A total sample of N=216 adults with T2DM and MDD will be recruited. Participants who meet eligibility criteria will be randomized at each site into 1 of 4 groups: usual care, CBT (10 individual sessions), community-based exercise (12 weeks) or CBT+EXER (10 individual sessions and 12 weeks of concurrent exercise). Intention-to-treat analyses will be conducted to assess primary and secondary outcomes. The study makes a significant contribution to the field by testing the effectiveness of separate and combination treatment modalities for T2DM and MDD in comparison to UC and implementing two manualized treatment programs (CBT and exercise) tailored for individuals with T2DM within community settings. The study is innovative in its approach to the design and implementation of the treatment of T2DM and MDD by creating a model for coordinated care for T2DM and MDD treatment across mental health and community exercise facilities and creating a sustainable program that can be adopted by community mental health and exercise facilities in rural regions nationally beyond the period of federal funding.

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水平低下的农村地区已达到流行病的程度。经济贫困人群患 T2DM 的风险增加，结果恶化。农村居民尤其受到贫困和医疗保健障碍的影响，而正是这些障碍导致了这些结果。四分之一的糖尿病患者患有抑郁症 (MDD)。抑郁症与血糖水平恶化和糖尿病并发症有关。抑郁症和 T2DM 还会导致巨大的成本，包括：对医疗保健系统的财务需求、依从性和生活质量的下降、由于各种原因导致的功能残疾和早期死亡率的增加。认知行为疗法 (CBT) 和锻炼能够协同工作，作为一种双赢策略，改善 T2DM 和 MDD 结局，同时减少农村地区流行的护理障碍。我们小组成功开展了一项名为“ACTIVE 计划”（阿巴拉契亚人齐心协力增加重要运动）的试点研究 (R34DK071545)，以测试在农村阿巴拉契亚地区患有 T2DM 的成年人中使用 CBT 和社区锻炼来招募、保留和改变结果的可行性。与基线相比，我们观察到治疗后和 3 个月随访 (3MFU) 时糖尿病、MDD 和 LDL-C 结果有所改善。 ACTIVE 计划的一项随机对照试验 (RCT) 旨在测试与单独运动、单独 CBT 和常规护理相比，联合行为治疗是否能更大程度地改善 MDD 和 T2DM 结局。该研究将采用 2X2 因子重复测量 RCT 设计，其中参与者将在基线、干预后 (POST)、6 个月和 12 个月的随访时间点进行评估。将使用先前试点研究中开发的干预材料。为俄亥俄州和西弗吉尼亚州中部阿巴拉契亚县农村地区服务的两个干预点将由印第安纳大学的 PI 进行协调。将招募总共 N=216 名患有 T2DM 和 MDD 的成年人样本。符合资格标准的参与者将在每个地点被随机分为 4 组中的一组：常规护理、CBT（10 次单独疗程）、社区锻炼（12 周）或 CBT+EXER（10 次单独疗程和 12 周同时锻炼）。将进行意向治疗分析以评估主要和次要结局。该研究通过测试 T2DM 和 MDD 的单独和联合治疗方式与 UC 相比的有效性，并在社区环境中为 T2DM 患者实施两种量身定制的手动治疗计划（CBT 和运动），对该领域做出了重大贡献。该研究在 T2DM 和 MDD 治疗的设计和实施方法上具有创新性，创建了一个跨心理健康和社区运动设施协调 T2DM 和 MDD 治疗护理的模型，并创建了一个可供社区心理健康机构采用的可持续计划。在联邦资助期限之外的全国农村地区的健康和运动设施。