Victor Teresa A, Khalsa Sahib S, Simmons W Kyle, Feinstein Justin S, Savitz Jonathan, Aupperle Robin L, Yeh Hung-Wen, Bodurka Jerzy, Paulus Martin P
Laureate Institute for Brain Research, Tulsa, Oklahoma, USA.
Oxley College of Health Sciences, University of Tulsa, Tulsa, Oklahoma, USA.
BMJ Open. 2018 Jan 24;8(1):e016620. doi: 10.1136/bmjopen-2017-016620.
Although neuroscience has made tremendous progress towards understanding the basic neural circuitry underlying important processes such as attention, memory and emotion, little progress has been made in applying these insights to psychiatric populations to make clinically meaningful treatment predictions. The overall aim of the Tulsa 1000 (T-1000) study is to use the NIMH Research Domain Criteria framework in order to establish a robust and reliable dimensional set of variables that quantifies the positive and negative valence, cognition and arousal domains, including interoception, to generate clinically useful treatment predictions.
The T-1000 is a naturalistic study that will recruit, assess and longitudinally follow 1000 participants, including healthy controls and treatment-seeking individuals with mood, anxiety, substance use and eating disorders. Each participant will undergo interview, behavioural, biomarker and neuroimaging assessments over the course of 1 year. The study goal is to determine how disorders of affect, substance use and eating behaviour organise across different levels of analysis (molecules, genes, cells, neural circuits, physiology, behaviour and self-report) to predict symptom severity, treatment outcome and long-term prognosis. The data will be used to generate computational models based on Bayesian statistics. The final end point of this multilevel latent variable analysis will be standardised assessments that can be developed into clinical tools to help clinicians predict outcomes and select the best intervention for each individual, thereby reducing the burden of mental disorders, and taking psychiatry a step closer towards personalised medicine.
Ethical approval was obtained from Western Institutional Review Board screening protocol #20101611. The dissemination plan includes informing health professionals of results for clinical practice, submitting results to journals for peer-reviewed publication, presenting results at national and international conferences and making the dataset available to researchers and mental health professionals.
NCT02450240; Pre-results.
尽管神经科学在理解诸如注意力、记忆和情感等重要过程背后的基本神经回路方面取得了巨大进展，但在将这些见解应用于精神疾病患者群体以做出具有临床意义的治疗预测方面进展甚微。塔尔萨1000（T - 1000）研究的总体目标是使用美国国立精神卫生研究所（NIMH）研究领域标准框架，以建立一套强大且可靠的维度变量集，该变量集量化积极和消极效价、认知和唤醒领域，包括内感受，以生成具有临床实用性的治疗预测。
T - 1000是一项自然主义研究，将招募、评估并纵向跟踪1000名参与者，包括健康对照者以及患有情绪、焦虑、物质使用和饮食失调的寻求治疗者。每位参与者将在1年的时间里接受访谈、行为、生物标志物和神经影像学评估。该研究的目标是确定情感、物质使用和饮食行为障碍如何在不同分析层面（分子、基因、细胞、神经回路、生理学、行为和自我报告）上组织起来，以预测症状严重程度、治疗结果和长期预后。这些数据将用于生成基于贝叶斯统计的计算模型。这种多层次潜在变量分析的最终终点将是标准化评估，可将其开发成临床工具，以帮助临床医生预测结果并为每个个体选择最佳干预措施，从而减轻精神障碍的负担，并使精神病学向个性化医学迈进一步。
已获得西部机构审查委员会筛查方案#20101611的伦理批准。传播计划包括将结果告知卫生专业人员以供临床实践参考，向期刊提交结果以供同行评审发表，在国内和国际会议上展示结果，并向研究人员和心理健康专业人员提供数据集。
NCT02450240；预结果。
