The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).
The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).
复制标题
DOI：
10.1016/j.cct.2020.106072
复制
发表时间：
2020-08
影响因子：
2.2
通讯作者：
Ma J
中科院分区：
文献类型：
--
作者：
Lv N;Ajilore OA;Ronneberg CR;Venditti EM;Snowden MB;Lavori PW;Xiao L;Goldstein-Piekarski AN;Wielgosz J;Wittels NE;Barve A;Patel AS;Eckley TL;Stetz P;Gerber BS;Smyth JM;Simmons JM;Rosas LG;Williams LM;Ma J
尽管有证据表明，有效的综合行为疗法治疗肥胖和抑郁症共病，治疗反应是高度可变的，潜在的神经生物学机制仍然未知。这阻碍了确定机制靶点以优化治疗精度和效力的努力。在NIH行为改变科学（SOBC）研究网络的资助下，两阶段的ENGAGE研究项目采用实验性的精准医学方法来解决这一差距。第一阶段研究的重点是证明技术可行性，目标参与和对综合行为疗法的反应的潜在神经机制。这种疗法结合了基于视频的行为减肥计划和抑郁症的问题解决疗法，并根据需要强化抗抑郁药物，其临床有效性在一项随机临床试验中得到了证明。在这里，我们描述了参与阶段2（ENGAGE-2）研究方案，以2种方式建立在第1阶段的基础上：（1）在一个独立的，主要是少数民族患者样本中对动机访谈增强的综合行为疗法进行试点测试，以及（2）评估先验定义的神经目标，特别是负面影响（威胁和悲伤）回路，其在第1阶段中表现出参与性和可塑性，作为治疗结果的介质。此外，2期研究包括概念和方法的扩展，以探索微生物组-肠-脑和全身免疫途径在肥胖和抑郁症综合行为治疗中的作用。该方案文件记录了ENGAGE-2的概念化，设计和跨学科方法，可以为未来的行为改变和慢性病管理实验精准医学的临床和转化研究提供信息。
Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management.
登录
查看更多内容
影响因子：
120.7
作者：
Flegal, Katherine M.;Carroll, Margaret D.;Curtin, Lester R.
通讯作者：
Curtin, Lester R.
DASH 治疗哮喘：针对未得到良好控制的成人哮喘的 DASH 饮食的初步研究。
影响因子：
2.2
作者：
Ma J;Strub P;Lavori PW;Buist AS;Camargo CA Jr;Nadeau KC;Wilson SR;Xiao L
通讯作者：
Xiao L
影响因子：
5
作者：
COHEN, S;KAMARCK, T;MERMELSTEIN, R
通讯作者：
MERMELSTEIN, R
影响因子：
10.6
作者：
Bruce-Keller AJ;Salbaum JM;Luo M;Blanchard E 4th;Taylor CM;Welsh DA;Berthoud HR
通讯作者：
Berthoud HR
DOI：
10.1001/jama.2017.3826
发表时间：
2017-04-18
期刊：
JAMA
影响因子：
--
作者：
Friedrich, M J
通讯作者：
Friedrich, M J