RCT on comanagement of obesity, depression, and elevated CVD risk in primary care

描述（由申请人提供）：同时存在肥胖和抑郁以及常见心脏代谢危险因素的患者是一级预防的关键目标群体，因为他们的患病率增加，糖尿病（DM）和心血管疾病的终生风险增加，但可能可逆。但是，对于如何在初级保健环境中以循证和实用的方式共同治疗这些疾病，人们知之甚少。拟议的研究将首次测试一种临床干预，该干预独特地整合了用于减肥的群体生活方式平衡（GLB）计划，这是糖尿病预防计划生活方式干预的“现实世界”翻译模型，以及用于抑郁症的PEARLS合作阶梯式护理计划，该计划使用问题解决疗法（PST）作为第一线，并通过逐步增加抗抑郁药物的剂量和数量进行必要的强化。肥胖、抑郁、同时存在代谢综合征、糖尿病前期和/或妊娠糖尿病史的成年人将成为目标患者群体。来自大型社区、多专业团体实践的符合条件和同意的初级保健患者（n=404）将随机接受12个月的联合治疗或常规护理。训练有素的健康教练在同一地点的精神病学和医疗监督下工作，将在5个月内提供8次一对一的PST课程，然后每月进行6次电话咨询。在第四次一对一训练中，教练将介绍带回家的GLB DVD，每周12次，并辅以持续的网络、手机和电子邮件教练对减肥和行为改变的支持。按照分步治疗方案，监督精神病医生将建议开始或调整抗抑郁药物给有持续症状的患者的主要提供者，如有必要，向患者提供电话咨询。随访评估将在6、12、18和24个月进行。主要目的是确定干预的有效性（RE-AIM模型中的“E”）。我们假设(1)与对照组相比，干预参与者将有更好的共同主要终点，即在12个月（治疗结束）时，平均BMI和20项抑郁症状检查表得分较低；(2)这些增加的干预效果将持续24个月（随访结束）；(3)根据增量成本（从卫生系统和社会角度估计）与增量收益（以获得的质量调整生命年表示）的比率，该干预措施将在2年内和预计的更长时间内显示成本效益。第二个目标是使用混合方法对RE-AIM的其他属性进行过程评估：覆盖面（例如，目标人群的参与率），采用（例如，参与诊所和提供者的特征），实施（例如，干预交付的保真度）和维护（例如，利益相关者对干预可持续性的看法）。我们还将探讨效果修饰剂和介质，以使干预细化，以获得最大的影响。在初级保健中治疗肥胖、抑郁和心脏代谢危险因素的综合多条件方法是新颖的，可能可扩展，具有很高的公共卫生影响潜力。

DESCRIPTION (provided by applicant): Patients with coexisting obesity and depression and common cardiometabolic risk factors are a critical target group for primary prevention because of their increasing prevalence and increased, but potentially reversible, lifetime risk for diabete mellitus (DM) and cardiovascular disease. But little is known about how to treat them in concert in ways that are evidence-based and practical in primary care settings. The proposed study will test, for the first time, a clinical intervention that uniquely integrates the Group Lifestyle Balace (GLB) program for weight loss, which is a "real-world" translated model of the Diabetes Prevention Program lifestyle intervention, with the PEARLS collaborative stepped care program for depression, which uses problem-solving therapy (PST) as first-line with as-needed intensification through stepwise increases in doses and number of antidepressant medications. Obese, depressed adults with coexisting metabolic syndrome, pre- DM, and/or history of gestational DM will be the target patient population. Eligible and consenting primary care patients (n=404) from a large, community-based, multispecialty group practice will be randomized to receive the combined treatment or usual care for 12 months. Trained health coaches, working under co-located psychiatric and medical supervision, will provide 8 1-on-1 PST sessions over 5 months followed by 6 monthly calls. At the 4th 1-on-1 session, the coach will introduce the take-home GLB DVD, which has 12 weekly sessions and is supplemented by ongoing Web-, mobile- and email-mediated coach support for weight loss and behavior change. Following a stepped-care protocol, the supervising psychiatrist will recommend initiating or adjusting anti- depressant medications to primary providers of patients with unremitting symptoms, and if necessary, provide phone consultations to patients. Follow-up assessments will occur at 6, 12, 18, and 24 months. The primary aim is to determine the effectiveness of the intervention ("E" in the RE-AIM model). We hypothesize (1) that compared with controls, intervention participants will have better co-primary endpoints, i.e., lower mean BMI and score on the 20-item Depression Symptom Checklist at 12 months (end of treatment); (2) that these incremental intervention benefits will persist through 24 months (end of follow-up); and (3) that the intervention will show cost-effectiveness within 2 years and over a projected longer term, based on the ratio of incremental costs (estimated from health system and societal perspectives) to incremental benefits (expressed as quality-adjusted life years gained). The secondary aim is to conduct process evaluation with mixed methods for the other RE-AIM attributes: Reach (e.g., participation rate of the target population), Adoption (e.g., characteristcs of participating clinics and providers), Implementation (e.g., fidelity of intervention delivery), nd Maintenance (e.g., stakeholders' perceptions of intervention sustainability). We will also explore effect modifiers and mediators to enable intervention refinement for maximum impact. The proposed integrated multicondition approach to treating obesity and depression and cardiometabolic risk factors in primary care is novel and likely scalable, with high public health impact potential.