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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coordinated Specialty Care (CSC)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring psychosis

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prevention and Recovery Center for Early PsychosisRecruiting
  • Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane UniversityRecruiting
  • Program for Risk Evaluation and Prevention (PREP) - University of MichiganRecruiting
  • Strong Ties Young Adults Program- University of Rochester Medical CenterRecruiting
  • The Early Psychosis Intervention Center (EPICENTER) at Ohio StateRecruiting
  • Vanderbilt's Early Psychosis Program - Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

CSC-SD

CSC-TH

Arm Description

Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.

Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.

Outcomes

Primary Outcome Measures

Annualized hospitalization rates
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

Number of participants hospitalized
Count of the number of participants hospitalized (adjusted for time in treatment)
Time (days) to first hospitalization
Count of the time in days to first hospitalization
Symptom and functioning outcomes assessed by the MIRECC-GAF
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.

Full Information

First Posted
July 31, 2020
Last Updated
May 16, 2023
Sponsor
Indiana University
Collaborators
University of Michigan, Ohio State University, Vanderbilt University, Tulane University, University of Rochester, Yale University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04497857
Brief Title
Academic-Community EPINET (AC-EPINET)
Acronym
AC-EPINET
Official Title
Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
University of Michigan, Ohio State University, Vanderbilt University, Tulane University, University of Rochester, Yale University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Major Depression With Psychotic Features, Bipolar Disorder With Psychotic Features
Keywords
psychosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSC-SD
Arm Type
Placebo Comparator
Arm Description
Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.
Arm Title
CSC-TH
Arm Type
Experimental
Arm Description
Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
Intervention Type
Other
Intervention Name(s)
Coordinated Specialty Care (CSC)
Intervention Description
CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders
Primary Outcome Measure Information:
Title
Annualized hospitalization rates
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants hospitalized
Description
Count of the number of participants hospitalized (adjusted for time in treatment)
Time Frame
12 months
Title
Time (days) to first hospitalization
Description
Count of the time in days to first hospitalization
Time Frame
12 months
Title
Symptom and functioning outcomes assessed by the MIRECC-GAF
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 16 and 35 years of age Able to give informed consent Willing and able to adhere to the study schedule New intakes enrolled in one of the six clinical programs 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Manager
Phone
3178808438
Email
iupdp@iupui.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Breier
Organizational Affiliation
Indiana Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention and Recovery Center for Early Psychosis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Manager, MSW
Phone
317-880-8495
Email
iupdp@iupui.edu
First Name & Middle Initial & Last Name & Degree
Alan Breier, MD
Facility Name
Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Weiss
Phone
504-236-5009
Email
aweiss3@tulane.edu
First Name & Middle Initial & Last Name & Degree
Ashley Weiss
Facility Name
Program for Risk Evaluation and Prevention (PREP) - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Taylor
Phone
734-764-0231
Email
sftaylor@med.umich.edu
Facility Name
Strong Ties Young Adults Program- University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Silverstein
Phone
585-275-6742
Email
Steven_Silverstein@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Steven Silverstein
Facility Name
The Early Psychosis Intervention Center (EPICENTER) at Ohio State
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Breitborde
Phone
614-685-6052
Facility Name
Vanderbilt's Early Psychosis Program - Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Vance
Phone
615-875-1401
First Name & Middle Initial & Last Name & Degree
Stephan Heckers

12. IPD Sharing Statement

Plan to Share IPD
No

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Academic-Community EPINET (AC-EPINET)

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