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Academic-Community EPINET (AC-EPINET) (AC-EPINET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497857
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : October 13, 2022
Sponsor:
Collaborators:
University of Michigan
Northwestern University
Vanderbilt University
Tulane University
University of Rochester
Yale University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alan Breier, Indiana University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Major Depression With Psychotic Features Bipolar Disorder With Psychotic Features Other: Coordinated Specialty Care (CSC) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
Actual Study Start Date : March 16, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: CSC-SD
Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.
 Other: Coordinated Specialty Care (CSC)
CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders
Experimental: CSC-TH
Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
 Other: Coordinated Specialty Care (CSC)
CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders


Outcome Measures
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Primary Outcome Measures :
  1. Annualized hospitalization rates [ Time Frame: 12 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 :
  1. Number of participants hospitalized [ Time Frame: 12 months ]
    Count of the number of participants hospitalized (adjusted for time in treatment)

  2. Time (days) to first hospitalization [ Time Frame: 12 months ]
    Count of the time in days to first hospitalization

  3. Symptom and functioning outcomes assessed by the MIRECC-GAF [ Time Frame: 12 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

1. Known IQ < 70 based on participant report

Contacts and Locations
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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): NCT04497857


Contacts
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Contact: Megan Gaunnac 3178808435 mmdelane@iupui.edu
Contact: Andrew Visco 3178808438 avisco@iupui.edu

Locations
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United States, Illinois
Recovery from Early Psychosis Program (REPP) - Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Morris Goldman    312-503-0866    mgoldman@nm.org   
Principal Investigator: Morris Goldman         
United States, Indiana
Prevention and Recovery Center for Early Psychosis Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Megan Gaunnac, MBA    317-880-8495    iupdp@iupui.edu   
Principal Investigator: Alan Breier, MD         
United States, Louisiana
Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University Recruiting
New Orleans, Louisiana, United States, 70119
Contact: Ashley Weiss    504-236-5009    aweiss3@tulane.edu   
Principal Investigator: Ashley Weiss         
United States, Michigan
Program for Risk Evaluation and Prevention (PREP) - University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ivy Tso    734-232-0373    ivytso@med.umich.edu   
Principal Investigator: Ivy Tso         
United States, New York
Strong Ties Young Adults Program- University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14623
Contact: Steven Silverstein    585-275-6742    Steven_Silverstein@urmc.rochester.edu   
Principal Investigator: Steven Silverstein         
United States, Tennessee
Vanderbilt's Early Psychosis Program - Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37212
Contact: Taylor Gautier    615-875-1401    taylor.gautier@vumc.org   
Principal Investigator: Stephan Heckers         
Sponsors and Collaborators
Indiana University
University of Michigan
Northwestern University
Vanderbilt University
Tulane University
University of Rochester
Yale University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Alan Breier Indiana Univeristy
More Information
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Responsible Party: Alan Breier, Senior Professor of Psychiatry, Indiana University
ClinicalTrials.gov Identifier: NCT04497857    
Other Study ID Numbers: epinet
5R01MH120588-02 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alan Breier, Indiana University:
psychosis
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
 Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders