Integrating NIMH Research Domain Criteria (RDoC) into assessing depression in the TENDAI Study

本申请正在按照NOT-TW-19-003的规定提交给PA-18-591。 获取抑郁症循证治疗的障碍，如治疗复杂性，意味着 艾滋病毒携带者(PLWH)很少在社区环境中接受抑郁症治疗。致信地址 在这一群体中，未得到满足的心理健康需求，父母赠款正在实施可扩展的阶梯式护理 艾滋病病毒携带者抑郁的干预及坚持抗逆转录病毒治疗 津巴布韦，通过双臂平行组随机临床试验。被称为天台的积极干预 包括简短的激励疗法和解决问题的疗法，并正在与增强型普通护理进行比较。 12个月后的主要结果是每种情况下HIV病毒抑制的比例。次要结果 在4个月、8个月和12个月时使用PHQ-9评估抑郁症。 津巴布韦卫生部是家长试验的合作伙伴，该地区的非政府组织希望 以更广泛地实施天台干预。然而，在资源不足的环境中，关键是 根据证据合理实施干预措施。我们将面对更大的障碍 执行缺乏关于谁将受益最大的知识。迫切需要对工具进行研究 这可能会指导实施具有成本效益的抑郁症护理。NIMH首创的RDOC 主动性为理解认知和情感干扰提供了一个生物学上有效的框架 这是严重抑郁症的特征，以及大脑系统在这些干扰中的作用。在美国，RDoC 认知控制和负效价的衡量标准已被发现有助于简化和匹配 为那些受益最大的人提供抑郁症的治疗。最终，这样的研究有望提供 脑健康解决方案，指导实施高性价比的抑郁症护理。然而，那里有 几乎没有关于中低收入人群抑郁症治疗反应预测因素的研究 国家/地区(LMIC)或PLWH。 在此补充应用程序中，我们建议集成NIMH研究领域标准(RDoC) 将认知和情感功能的RDoC指标与Strong 与严重的抑郁症有关。这将使我们能够确定认知控制、 负价，以及在PLWH中抑郁的标准测量，以及确定RDoC 指标预测PLWH中抑郁治疗的反应。这项研究将是收集 RDoC框架有助于指导可伸缩STEP实施的概念证明 PLWH低收入国家背景下的护理神经健康干预措施。我们的工作直接链接到 NIMH优先使用已经收集的数据来模拟和检验干预措施之间的因果关系， 干预目标、近期和临床结果。

This application is being submitted to PA-18-591 in accordance with NOT-TW-19-003. Barriers to accessing evidence-based treatments for depression, such as treatment complexity, mean that people living with HIV (PLWH) rarely receive depression therapies in community settings. To address unmet mental health needs within this group, the parent grant is implementing a scalable stepped-care intervention for depression and adherence to antiretroviral therapy in viraemic people living with HIV in Zimbabwe, through a 2-arm parallel group randomized clinical trial. The active intervention, called TENDAI includes brief motivational and problem-solving therapy, and is being compared with Enhanced Usual Care. Primary outcome at 12 months is proportion of HIV viral suppression in each condition. Secondary outcome is depression assessed at 4, 8 and 12 months using the PHQ-9. The Ministry of Health in Zimbabwe, who are partners in the parent trial, and NGOs in the region, would like to implement the TENDAI intervention more widely. However, in low-resource settings it will be critical to rationalise implementation of interventions in line with evidence. A barrier we will face to wider implementation is lack of knowledge as to who will benefit most. Research is urgently needed on tools which might guide the implementation of cost-effective depression care. The NIMH-pioneered RDoC initiative presents a biologically valid framework for understanding the cognitive and affective disruptions that characterize major depression and the role of brain systems in these disruptions. In the US, RDoC metrics of cognitive control and negative valence, have been found to aid in streamlining and matching treatments for depression to those who will benefit most. Ultimately, such research is hoped to provide brain heath solutions to guide the implementation of cost-effective depression care. However there has been virtually no research on predictors of depression treatment response in low and middle income countries (LMICs) or in PLWH. In this supplemental application, we propose to integrate the NIMH Research Domain Criteria (RDoC) initiative into the TENDAI trial by incorporating RDoC metrics of cognitive and affective function with strong links to major depression. This will allow us to determine baseline associations between cognitive control, negative valence, and standard measures of depression in PLWH, as well as determine whether RDoC metrics predict depression treatment response in PLWH. This research will be a vital first step in gathering proof of concept that the RDoC framework can contribute to guiding implementation of scalable stepped care neuro-health interventions in a low-income country context in PLWH. Our work links directly to the NIMH priority to use data already being collected to model and test causal relations among interventions, intervention targets, and proximal and clinical outcomes.