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Latent Structure of Multi-level Assessments and Predictors of Outcomes for Women in Recovery

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ClinicalTrials.gov Identifier: NCT02601495
Recruitment Status : Active, not recruiting
First Posted : November 10, 2015
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
University of Oklahoma
Rutgers University
University of California, San Diego
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Depression Anxiety Eating Disorders Drug Use Disorders Stress Disorders, Post-Traumatic Behavioral: Women in a court diversion program

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 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Latent Structure of Multi-level Assessments and Predictors of Outcomes for Women in Recovery
Actual Study Start Date : November 2015
Actual Primary Completion Date : January 2020
Estimated Study Completion Date : November 2028

Group/Cohort Intervention/treatment
Women in a court diversion program
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.




Primary Outcome Measures :
  1. Change from Baseline in Clinical Diagnosis [ Time Frame: Baseline to 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


Biospecimen Retention:   Samples With DNA
Whole Blood, Serum, Plasma, Microbiome


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women enrolled in a court diversion program called Women in Recovery.
Criteria

Inclusion Criteria:

  1. Enrolled in the Women in Recovery (WIR) program and reporting problems with:

    1. Anxiety and/or depressive symptoms
    2. Trauma-related symptoms
    3. Problems related to substance use
    4. Problems related to eating behavior
  2. Screened positive for problems in (1) as indicated by:

    1. Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
    2. PTSD Checklist (PCL) ≥30
    3. Drug Abuse Screening Test (DAST-10) score > 2
    4. Eating Disorder Screen (SCOFF) score ≥ 2
  3. Have a body mass index between 17 to 38 kg/m²
  4. Able to provide written informed consent.
  5. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion Criteria:

  1. No telephone or easy access to telephone.
  2. 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.
  3. A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
  4. Has any of the following Diagnostic and Statistical Manual (DSM-V) disorders:

    1. Schizophrenia Spectrum and Other Psychotic Disorders
    2. Bipolar and Related Disorders
    3. Obsessive-Compulsive and Related Disorders
  5. Moderate to severe traumatic brain injury or other neurocognitive disorder
  6. Active suicidal ideation with intent or plan.
  7. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning
  8. Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research.
  9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day)
  10. MRI contraindications
  11. Unwillingness or inability to complete any of the major aspects of the study protocol Non-correctable vision or hearing problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601495


Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
University of Oklahoma
Rutgers University
University of California, San Diego
Investigators
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Principal Investigator: Martin P. Paulus, M.D. Laureate Institute for Brain Research
Publications:
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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02601495    
Other Study ID Numbers: 2015-009
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Feeding and Eating Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders