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

NCT02601495 | Active Not Recruiting

• 1 other identifier: 2015-009
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Anxiety; Eating Disorders; Drug Use Disorders; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 1 year

Study Arms (1)

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

Interventions

Women in a court diversion program BEHAVIORAL

Women in Recovery (WIR) is an intensive outpatient alternative for eligible women facing long prison sentences for non-violent, drug-related offenses in Oklahoma.

Women in a court diversion program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women enrolled in a court diversion program called Women in Recovery.

You may qualify if:

• Enrolled in the Women in Recovery (WIR) program and reporting problems with:
• Anxiety and/or depressive symptoms
• Trauma-related 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) ≥ 8.
• PTSD Checklist (PCL) ≥30
• 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.

You may not qualify if:

• 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 Diagnostic and Statistical Manual (DSM-V) disorders:
• Schizophrenia Spectrum and Other Psychotic Disorders
• Bipolar and Related Disorders
• Obsessive-Compulsive and Related Disorders
• 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

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• University of Oklahoma: collaborator
• Rutgers University: collaborator
• University of California, San Diego: collaborator

Related Publications (2)

• Insel T, Cuthbert B, Garvey M, Heinssen R, Pine DS, Quinn K, Sanislow C, Wang P. Research domain criteria (RDoC): toward a new classification framework for research on mental disorders. Am J Psychiatry. 2010 Jul;167(7):748-51. doi: 10.1176/appi.ajp.2010.09091379. No abstract available.

  PMID: 20595427 BACKGROUND

• Sanislow CA, Pine DS, Quinn KJ, Kozak MJ, Garvey MA, Heinssen RK, Wang PS, Cuthbert BN. Developing constructs for psychopathology research: research domain criteria. J Abnorm Psychol. 2010 Nov;119(4):631-9. doi: 10.1037/a0020909.

  PMID: 20939653 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Serum, Plasma, Microbiome

MeSH Terms

Conditions

Depression; Anxiety Disorders; Feeding and Eating Disorders; Substance-Related Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Martin P. Paulus, M.D.

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2020
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 14, 2023

Record last verified: 2023-08