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

将 NIMH 研究领域标准 (RDoC) 纳入 TENDAI 研究中的抑郁症评估

• 批准号: 9933575
• 负责人: MELANIE AMNA ABAS
• 金额: $ 12.22万
• 依托单位: KING'S COLLEGE LONDON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9933575
• 关键词: Acute; Address; Adherence; Affective; Anxiety; Back; Biological; Brain; Caring; Clinic; Clinical; Clinical Trials; Cognitive; Collection; Communities; Comorbidity; Counseling; Data; Depressed mood; Effectiveness; Evidence based treatment; Face; Fluoxetine; Funding; HIV; Health; Heterogeneity; High Prevalence; International; Intervention; Interview; Knowledge; Link; Major Depressive Disorder; Measures; Mental Depression; Mental Health; Mental disorders; Modeling; Motivation; National Institute of Mental Health; Negative Valence; Neuropsychology; Nurses; Outcome; Parents; Participant; Patient Self-Report; Patients; Performance; Pharmaceutical Preparations; Post-Traumatic Stress Disorders; Primary Health Care; Professional counselor; Property; Psychiatric Nursing; Psychiatry; Psychometrics; Publishing; Quality of life; Questionnaires; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Domain Criteria; Resources; Role; Rural; System; Testing; Training; Translating; Translations; Treatment outcome; Universities; Viral; Work; Zimbabwe; antiretroviral therapy; arm; cognitive control; cognitive system; cognitive testing; community setting; cost effective; depressive symptoms; implementation science; improved; low and middle-income countries; low income country; minor depressive disorder; parent grant; primary outcome; problem solving therapy; psychoeducation; response; secondary outcome; standard measure; symptomatology; therapy adherence; tool; treatment as usual; treatment response; virtual

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.

该申请根据NOT-TW-19-003提交给PA-18-591。 获得基于证据的抑郁症治疗的障碍，例如治疗复杂性，意味着 感染艾滋病毒（PLWH）的人很少在社区环境中接受抑郁疗法。解决 该小组中未满足的心理健康需求，父母赠款正在实施可扩展的步进措施 抑郁和遵守抗逆转录病毒疗法的病毒性艾滋病毒患者的干预措施 津巴布韦，通过一项2臂平行组随机临床试验。主动干预，称为Tendai 包括简短的动机和解决问题的疗法，并正在与增强的常规护理进行比较。 12个月时的主要结果是每种情况下HIV病毒抑制的比例。次要结果 使用PHQ-9在4、8和12个月评估抑郁症。 津巴布韦的卫生部是父母审判的合伙人，以及该地区的非政府组织，希望 更广泛地实施Tendai干预措施。但是，在低资源设置中，至关重要 合理地将干预措施实施与证据一致。我们将面对更广泛的障碍 实施是缺乏关于谁将受益最大的知识。迫切需要在工具上进行研究 这可能指导实施具有成本效益的抑郁症护理。 NIMH-PIONEERED RDOC 主动性提出了一个具有生物学上有效的框架，以理解认知和情感破坏 这是重大抑郁症和大脑系统在这些干扰中的作用的特征。在美国，RDOC 认知控制和负价的指标已被发现有助于精简和匹配 抑郁症的治疗给那些受益最大的人。最终，希望这样的研究能够提供 大脑健康解决方案，以指导实施具有成本效益的抑郁症护理。但是有 几乎没有关于低收入和中等收入中抑郁症治疗反应预测指标的研究 国家（LMIC）或PLWH。 在此补充应用中，我们建议整合NIMH研究领域标准（RDOC） 通过将认知和情感功能的RDOC指标纳入了Tendai试验的倡议 与重度抑郁症的链接。这将使我们能够确定认知控制之间的基线关联， 负价和PLWH中抑郁症的标准度量，并确定RDOC是否 指标预测PLWH中的抑郁治疗反应。这项研究将是收集的至关重要的第一步 RDOC框架可以有助于指导实施可伸缩的概念证明 在PLWH的低收入国家环境中，护理神经健康干预措施。我们的工作直接链接到 NIMH优先级，使用已经收集的数据来建模和测试干预措施之间的因果关系， 干预目标以及近端和临床结果。