<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497857</url>
  </required_header>
  <id_info>
    <org_study_id>epinet</org_study_id>
    <secondary_id>5R01MH120588-02</secondary_id>
    <nct_id>NCT04497857</nct_id>
  </id_info>
  <brief_title>Academic-Community EPINET (AC-EPINET)</brief_title>
  <acronym>AC-EPINET</acronym>
  <official_title>Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tulane University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH)&#xD;
      versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month,&#xD;
      randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      180 subjects will be randomized into a 12 month study, to one of two treatment arms. The&#xD;
      investigators will assess four important elements of engagement to determine which are most&#xD;
      sensitive to TH treatment and mediates effects on hospitalization rates. The investigators&#xD;
      will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a&#xD;
      training manual for implementing TH in CSC clinics and for use in future research. Although&#xD;
      this study has exploratory aims consistent with pilot projects, The investigators have&#xD;
      incorporated methodological rigor where possible (randomization, powering for hospitalization&#xD;
      rate) in order to achieve the most robust data to assess the main study questions and inform&#xD;
      future trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 16, 2022</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Annualized hospitalization rates</measure>
    <time_frame>12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants hospitalized</measure>
    <time_frame>12 months</time_frame>
    <description>Count of the number of participants hospitalized (adjusted for time in treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (days) to first hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>Count of the time in days to first hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom and functioning outcomes assessed by the MIRECC-GAF</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <condition>Schizophreniform Disorders</condition>
  <condition>Major Depression With Psychotic Features</condition>
  <condition>Bipolar Disorder With Psychotic Features</condition>
  <arm_group>
    <arm_group_label>CSC-SD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSC-TH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coordinated Specialty Care (CSC)</intervention_name>
    <description>CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders</description>
    <arm_group_label>CSC-SD</arm_group_label>
    <arm_group_label>CSC-TH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 16 and 35 years of age&#xD;
&#xD;
          2. Able to give informed consent&#xD;
&#xD;
          3. Willing and able to adhere to the study schedule&#xD;
&#xD;
          4. New intakes enrolled in one of the six clinical programs&#xD;
&#xD;
          5. Non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major&#xD;
             depression with psychotic features, bipolar disorder with psychotic features)&#xD;
             psychotic disorders with onsets within 5 years of enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Known IQ &lt; 70 based on participant report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Breier</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana Univeristy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Research Manager</last_name>
    <phone>3178808438</phone>
    <email>iupdp@iupui.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Prevention and Recovery Center for Early Psychosis</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Manager, MSW</last_name>
      <phone>317-880-8495</phone>
      <email>iupdp@iupui.edu</email>
    </contact>
    <investigator>
      <last_name>Alan Breier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Weiss</last_name>
      <phone>504-236-5009</phone>
      <email>aweiss3@tulane.edu</email>
    </contact>
    <investigator>
      <last_name>Ashley Weiss</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Program for Risk Evaluation and Prevention (PREP) - University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan Taylor</last_name>
      <phone>734-764-0231</phone>
      <email>sftaylor@med.umich.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Strong Ties Young Adults Program- University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Silverstein</last_name>
      <phone>585-275-6742</phone>
      <email>Steven_Silverstein@urmc.rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Steven Silverstein</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Early Psychosis Intervention Center (EPICENTER) at Ohio State</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicholas Breitborde</last_name>
      <phone>614-685-6052</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanderbilt's Early Psychosis Program - Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Vance</last_name>
      <phone>615-875-1401</phone>
    </contact>
    <investigator>
      <last_name>Stephan Heckers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Alan Breier</investigator_full_name>
    <investigator_title>Senior Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>psychosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497857
org study id: epinet
secondary id: 5R01MH120588-02
nct id: NCT04497857
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Annualized hospitalization rates
time frame: 12 months
description: 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
measure: Number of participants hospitalized
time frame: 12 months
description: Count of the number of participants hospitalized (adjusted for time in treatment)
measure: Time (days) to first hospitalization
time frame: 12 months
description: Count of the time in days to first hospitalization
measure: Symptom and functioning outcomes assessed by the MIRECC-GAF
time frame: 12 months
description: 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.
arm group label: CSC-SD
arm group type: Placebo Comparator
description: Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.
arm group label: CSC-TH
arm group type: Experimental
description: Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
intervention type: Other
intervention name: Coordinated Specialty Care (CSC)
description: CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders
arm group label: CSC-SD
arm group label: CSC-TH
criteria: 
gender: All
minimum age: 16 Years
maximum age: 35 Years
healthy volunteers: No
last name: Alan Breier
role: Principal Investigator
affiliation: Indiana Univeristy
last name: Research Manager
phone: 3178808438
email: iupdp@iupui.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Alan Breier
investigator title: Senior Professor of Psychiatry
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No