T-1000: Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,271
- 试验地点
- 1
- 主要终点
- Change from Baseline in Clinical Diagnosis
研究概览
简要总结
In this study the investigators will seek to improve our understanding of how positive and negative valence systems, cognition, and arousal/interoception are inter-related in disorders of mood, substance use, and eating behavior. The investigators will recruit 1000 individuals and use a wide range of assessment tools, neuroimaging measures, blood and microbiome collections and behavioral tasks to complete the baseline and follow-up study visits. Upon completion, the investigators aim to have robust and reliable dimensional measures that quantify these systems and a set of assessments that should be recommended as a clinical tool to enhance outcome prediction for the clinician and assist in determining who will likely benefit from what type of intervention.
详细描述
Neuroscience has made tremendous progress in understanding the basic neural circuitry that underlies important processes such as attention, memory, and basic emotion processing. Yet, little progress has been made to utilize these insights to apply them to psychiatric populations in order to make clinically meaningful predictions. The connection between psychiatric disorders and their underlying neurobiology has been difficult to establish. The overarching theme of this study is to determine how biological and objective behavioral measures can contribute to improving assessment and treatment of psychiatric patients. The investigators will use the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) framework as a heuristic approach that integrates neuroscience and psychopathology to study the positive and negative valence systems, cognition and arousal/interoception domains. Within this framework we will study a group of treatment seeking individuals with mental health conditions to determine how dysfunctions of affect, substance use, and eating behavior organize across different levels and whether these latent factors can be used to generate clinically useful prediction.
Using self-report, behavior, physiology, neural circuit, cell, molecule, and gene unit of analysis measures, the investigators propose to enroll 1000 individuals from four different cohorts over 5 years: (1) anxiety and/or depression; (2) eating problems; (3) substance use problems; and (4) healthy controls. Each individual will undergo a multi-level assessment that consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires, (c) behavioral tasks, (d) physiological measurements, (e) structural and functional magnetic resonance imaging (fMRI) and EEG, (f) biomarker and microbiome assessments, (g) blood to derive induced pluripotent stem cells, (h) and genetic and epigenetic assessments. These individuals will be followed up for one year and will be re-assessed using a multi-domain assessment of functioning, which will include: (a) symptom severity and duration, (b) subjective well-being, (c) psychosocial function, (c) occupational function, (d) physical health, (e) utilization of mental health resources (treatment), and (f) compliance with treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred or seeking treatment, as defined by answering yes to "have you sought help for problems with":
- •Anxiety and/or depressive symptoms
- •Problems related to substance use
- •Problems related to eating behavior
- •Screened positive for problems in (1) as indicated by:
- •Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥
- •Drug Abuse Screening Test (DAST-10) score > 2
- •Eating Disorder Screen (SCOFF) score ≥ 2
- •Have a body mass index between 17 to 38 kg/m²
- •Able to provide written informed consent.
- •Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.
排除标准
- •No telephone or easy access to telephone.
- •Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- •A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
- •Has any of the following DSM-V disorders:
- •Schizophrenia Spectrum and Other Psychotic Disorders
- •Bipolar and Related Disorders
- •Obsessive-Compulsive and Related Disorders
- •Antisocial Personality Disorder
- •Moderate to severe traumatic brain injury or other neurocognitive disorder
- •Active suicidal ideation with intent or plan.
- •Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning
- •Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research.
- •Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day)
- •MRI contraindications
- •Unwillingness or inability to complete any of the major aspects of the study protocol
- •Non-correctable vision or hearing problems
结局指标
主要结局
Change from Baseline in Clinical Diagnosis
时间窗: Baseline and 1 year
Test the predictive effects of endophenotypes (genetic, imaging and behavioral factors) on clinical diagnosis at baseline compared to one year later using the Mini International Psychiatric Interview in patients and healthy controls
次要结局
未报告次要终点