An observational study in Depression, Anxiety and Eating Disorders, sponsored by Laureate Institute for Brain Research, Inc.. Active, not recruiting. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Laureate Institute for Brain Research, Inc. · Observational
In this study the investigators will seek to improve their understanding of how positive and negative valence systems, cognition, and arousal/interoception are inter-related in disorders of trauma, mood, substance use, and eating behavior for women involved in a court diversion program in Tulsa, Oklahoma (Women in Recovery). The investigators will recruit 100 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 the diversion program, and to inform future revision or augmentation of the program to increase treatment effectiveness.
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 women who attend a court diversion program (Women in Recovery [WIR]) that includes treatment for mental health symptoms. 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 the investigators 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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 100 is below the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Laureate Institute for Brain Research, Inc. is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women enrolled in a court diversion program called Women in Recovery.
Enrolled in the Women in Recovery (WIR) program and reporting problems with:
Screened positive for problems in (1) as indicated by:
Exclusion Criteria:
Has any of the following Diagnostic and Statistical Manual (DSM-V) disorders:
Women enrolled in the court diversion program in Tulsa, Oklahoma called Women in Recovery who report symptoms related to anxiety or depressive symptoms (Patient Health Questionnaire score ≥ 10 and/or Overall Anxiety Severity and Impairment Scale ≥ 8), problematic eating behavior(Eating Disorder Screen score ≥ 2), problems related to substance use (Drug Abuse Screening Test score \> 2), or post traumatic stress disorder symptoms (PTSD Checklist score ≥ 30).
Behavioral: Women in a court diversion program
Women in Recovery (WIR) is an intensive outpatient alternative for eligible women facing long prison sentences for non-violent, drug-related offenses in Oklahoma.
Change from Baseline in Clinical Diagnosis
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
Time frame: Baseline to 1 year
No study locations are listed for this record.
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Laureate Institute for Brain Research, Inc.