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.

本申请根据NOT-TW-19-003提交给PA-18-591。 获得抑郁症循证治疗的障碍，如治疗复杂性，意味着 艾滋病毒感染者（PLWH）很少在社区环境中接受抑郁症治疗。解决 在这一群体中未得到满足的心理健康需求，父母补助金正在实施一项可扩展的阶梯式护理， 艾滋病病毒血症患者抑郁症干预和抗逆转录病毒治疗依从性 津巴布韦，通过2组平行组随机临床试验。积极干预，称为TENDAI 包括简短的动机和解决问题的治疗，并正在与增强型精神病护理进行比较。 12个月时的主要结局是每种情况下HIV病毒抑制的比例。次要结局 是使用PHQ-9在4、8和12个月时评估的抑郁症。 津巴布韦卫生部是父母试验的合作伙伴，该地区的非政府组织希望 更广泛地实施TENDAI干预措施。然而，在资源匮乏的环境中， 根据证据合理实施干预措施。一个我们将面对的更大的障碍 执行方面缺乏对谁将受益最大的了解。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 倡议提出了一个生物学上有效的框架，以了解认知和情感的破坏， 抑郁症的特征以及大脑系统在这些破坏中的作用。在美国，RDoC 认知控制和负效价的度量，已被发现有助于精简和匹配 治疗抑郁症的人将受益最多。最终，这样的研究有望提供 脑健康解决方案，以指导实施具有成本效益的抑郁症护理。然而， 几乎没有关于低收入和中等收入人群中抑郁症治疗反应的预测因素的研究 低收入国家或艾滋病毒携带者和艾滋病患者。 在本补充申请中，我们建议将NIMH研究领域标准（RDoC） 通过将认知和情感功能的RDoC指标与强大的 与重度抑郁症有关这将使我们能够确定认知控制， 负效价和PLWH抑郁症的标准措施，以及确定是否RDoC 指标预测PLWH中抑郁治疗反应。这项研究将是至关重要的第一步， RDoC框架有助于指导可扩展的分步实施的概念证明 在低收入国家的背景下，在PLWH的护理神经健康干预措施。我们的工作直接与 NIMH优先使用已经收集的数据来模拟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局。