Academic-Community EPINET (AC-EPINET)

NCT ID: NCT04497857

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2025-07-29

Brief Summary

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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

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160 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.

Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Major Depression With Psychotic Features Bipolar Disorder With Psychotic Features

Keywords

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psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CSC-SD

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

Group Type PLACEBO_COMPARATOR

Coordinated Specialty Care (CSC)

Intervention Type OTHER

CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

CSC-TH

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

Group Type EXPERIMENTAL

Coordinated Specialty Care (CSC)

Intervention Type OTHER

CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

Interventions

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Coordinated Specialty Care (CSC)

CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Alan Breier

Raymond E. Houk Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Breier

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Prevention and Recovery Center for Early Psychosis

Indianapolis, Indiana, United States

Site Status

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

New Orleans, Louisiana, United States

Site Status

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

Ann Arbor, Michigan, United States

Site Status

Strong Ties Young Adults Program- University of Rochester Medical Center

Rochester, New York, United States

Site Status

The Early Psychosis Intervention Center (EPICENTER) at Ohio State

Columbus, Ohio, United States

Site Status

Vanderbilt's Early Psychosis Program - Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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5R01MH120588-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

epinet

Identifier Type: -

Identifier Source: org_study_id