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Academic-Community EPINET (AC-EPINET)

Not Applicable
Recruiting
Conditions
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Major Depression with Psychotic Features
Bipolar Disorder with Psychotic Features
Interventions
Other: Coordinated Specialty Care (CSC)
Registration Number
NCT04497857
Lead Sponsor
Indiana University
Brief Summary

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.

Detailed Description

180 subjects will be randomized into a 12 month study, to one of two treatment arms. The investigators will assess four important elements of engagement to determine which are most sensitive to TH treatment and mediates effects on hospitalization rates. The investigators will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a training manual for implementing TH in CSC clinics and for use in future research. Although this study has exploratory aims consistent with pilot projects, The investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
180
Inclusion Criteria
  1. Between 16 and 35 years of age
  2. Able to give informed consent
  3. Willing and able to adhere to the study schedule
  4. New intakes enrolled in one of the six clinical programs
  5. Non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major depression with psychotic features, bipolar disorder with psychotic features) psychotic disorders with onsets within 5 years of enrollment.
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Exclusion Criteria
  1. Known IQ < 70 based on participant report
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CSC-SDCoordinated Specialty Care (CSC)Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.
CSC-THCoordinated Specialty Care (CSC)Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
Primary Outcome Measures
NameTimeMethod
Annualized hospitalization rates12 months

To determine if CSC-TH, as compared to CSC-SD, is associated with superior clinical outcomes by counting the number of hospitalizations in a year

Secondary Outcome Measures
NameTimeMethod
Time (days) to first hospitalization12 months

Count of the time in days to first hospitalization

Symptom and functioning outcomes assessed by the MIRECC-GAF12 months

The MIRECC GAF is a three scale assessment of symptom severity, occupational/school functioning, and social functioning. It is scored from 0-100, with a lower score representing worse symptoms/functioning and higher scores representing better functioning. This assessment has been found to have high levels of reliability, concurrent, and predictive validity. It is completed by a trained rater and is expected to take 5 minutes to complete, as the information needed to score the participants will be gathered in various aspects of the assessment process.

Number of participants hospitalized12 months

Count of the number of participants hospitalized (adjusted for time in treatment)

Trial Locations

Locations (6)

Prevention and Recovery Center for Early Psychosis

🇺🇸

Indianapolis, Indiana, United States

Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University

🇺🇸

New Orleans, Louisiana, United States

Program for Risk Evaluation and Prevention (PREP) - University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

Strong Ties Young Adults Program- University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

The Early Psychosis Intervention Center (EPICENTER) at Ohio State

🇺🇸

Columbus, Ohio, United States

Vanderbilt's Early Psychosis Program - Vanderbilt University

🇺🇸

Nashville, Tennessee, United States

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