Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
- Conditions
- Drug Use DisordersDepressionAnxietyEating Disorders
- Interventions
- Behavioral: standardized diagnostic assessmentBehavioral: self-report questionnairesBehavioral: behavioral tasksOther: physiological measurementsOther: structural and functional magnetic resonance imaging and EEGOther: biomarker and microbiome assessmentsOther: blood to derive induced pluripotent stem cellsOther: genetic and epigenetic assessments
- Registration Number
- NCT02450240
- Lead Sponsor
- Laureate Institute for Brain Research, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1271
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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
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Screened positive for problems in (1) as indicated by:
- Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
- Drug Abuse Screening Test (DAST-10) score > 2
- Eating Disorder Screen (SCOFF) score ≥ 2
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Have a body mass index between 17 to 38 kg/m²
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Able to provide written informed consent.
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Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.
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No telephone or easy access to telephone.
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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.
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A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
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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
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Moderate to severe traumatic brain injury or other neurocognitive disorder
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Active suicidal ideation with intent or plan.
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Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning
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Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research.
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Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day)
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MRI contraindications
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Unwillingness or inability to complete any of the major aspects of the study protocol
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Non-correctable vision or hearing problems
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Depression and Anxiety Disorders behavioral tasks 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders self-report questionnaires 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders standardized diagnostic assessment 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders structural and functional magnetic resonance imaging and EEG 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders genetic and epigenetic assessments 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders physiological measurements 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders biomarker and microbiome assessments 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Depression and Anxiety Disorders blood to derive induced pluripotent stem cells 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders physiological measurements 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders standardized diagnostic assessment 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders physiological measurements 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls physiological measurements 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders standardized diagnostic assessment 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders blood to derive induced pluripotent stem cells 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders biomarker and microbiome assessments 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders self-report questionnaires 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders behavioral tasks 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders biomarker and microbiome assessments 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls standardized diagnostic assessment 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders structural and functional magnetic resonance imaging and EEG 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Eating Disorders genetic and epigenetic assessments 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders self-report questionnaires 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders behavioral tasks 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls structural and functional magnetic resonance imaging and EEG 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls biomarker and microbiome assessments 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls genetic and epigenetic assessments 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders structural and functional magnetic resonance imaging and EEG 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders blood to derive induced pluripotent stem cells 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Substance Use Disorders genetic and epigenetic assessments 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score \> 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls self-report questionnaires 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls behavioral tasks 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Healthy Controls blood to derive induced pluripotent stem cells 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments.
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinical Diagnosis 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Laureate Institute for Brain Research
🇺🇸Tulsa, Oklahoma, United States