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

描述(由申请人提供)：肥胖和抑郁并存以及常见的心脏代谢危险因素的患者是一级预防的关键目标群体，因为他们的患病率不断上升，糖尿病(DM)和心血管疾病的终身风险增加，但可能是可逆的。但对于如何在初级保健环境中以循证和实用的方式协同治疗它们，人们知之甚少。这项拟议的研究将首次测试一种临床干预措施，该干预措施独特地将团体Lifestyle Balace(GLB)减肥计划与PEARLS协作分级护理计划结合在一起，前者是糖尿病预防计划生活方式干预的“现实世界”翻译模型，后者使用问题解决疗法(PST)作为一线，通过逐步增加剂量和抗抑郁药物的数量根据需要进行强化。肥胖、抑郁的成年人同时存在代谢综合征、糖尿病前期和/或妊娠期糖尿病病史将是目标患者群体。来自大型、社区、多专科团体诊所的符合条件并同意的初级保健患者(n=404)将随机接受联合治疗或常规护理12个月。训练有素的健康教练在同一地点的精神和医疗监督下工作，将在5个月内提供8次一对一的PST课程，然后每月提供6次电话。在第四次一对一的会议上，教练将推出带回家的GLBDVD，该DVD每周有12次会议，并辅之以持续的网络、移动和电子邮件中介的教练支持减肥和行为改变。根据分级护理方案，监督精神科医生将建议开始或调整抗抑郁药物的主要提供者的患者的持续症状，并在必要时，提供电话咨询的患者。6个月、12个月、18个月和24个月将进行后续评估。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项抑郁症状检查表上的得分更低；(2)这些增量干预益处将持续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(表示为获得的质量调整生命年)的比率，干预将在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：REACH(目标人群的参与率)、采纳性(例如参与诊所和提供者的特征)、实施(例如干预提供的保真度)和维护(例如利益相关者对干预可持续性的看法)。我们还将探索效果修饰剂和调解器，以实现最大影响的干预细化。建议的综合多条件方法在初级保健中治疗肥胖症和抑郁症以及心脏代谢危险因素是新颖的，可能是可推广的，具有很高的公共健康影响潜力。

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.