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.

此申请根据 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，例如治疗的复杂性，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。致地址 该群体的心理健康需求未得到满足，家长补助金正在实施可扩展的分级护理 对艾滋病病毒感染者进行抑郁干预和坚持抗逆转录病毒治疗 津巴布韦，通过2组平行组随机临床试验。主动干预，称为 TENDAI 包括简短的激励和解决问题的疗法，并与增强的日常护理进行比较。 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 是使用 PHQ-9 在 4、8 和 12 个月时评估的抑郁症。 作为母体试验的合作伙伴的津巴布韦卫生部以及该地区的非政府组织希望 更广泛地实施 TENDAI 干预。然而，在资源匮乏的环境中，至关重要的是 根据证据合理化干预措施的实施。我们将面临更广泛的障碍 实施过程中缺乏关于谁将受益最多的知识。工具亟需研究 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 该倡议提出了一个生物学上有效的框架来理解认知和情感干扰 重度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 认知控制和负价的指标被发现有助于简化和匹配 抑郁症的治疗方法对那些受益最大的人来说。最终，此类研究有望提供 大脑健康解决方案指导实施具有成本效益的抑郁症护理。然而有 实际上没有对低收入和中等收入人群抑郁症治疗反应的预测因素进行研究 国家 (LMIC) 或 PLWH。 在此补充申请中，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 TENDAI 试验中， 与重度抑郁症的联系。这将使我们能够确定认知控制之间的基线关联， 负价和 PLWH 抑郁症的标准测量，以及确定 RDoC 是否 指标可预测 PLWH 的抑郁治疗反应。这项研究将是收集信息的重要第一步 概念证明 RDoC 框架有助于指导可扩展阶梯的实施 在低收入国家对 PLWH 进行护理神经健康干预。我们的工作直接与 NIMH 优先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， 干预目标以及近期和临床结果。