Academic-Community EPINET (AC-EPINET)

Schizophrenia Clinical Trial

— AC-EPINET  

Official title:

Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497857
• Other study ID #: epinet
• Secondary ID: 5R01MH120588-02
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: Research Manager
• Phone: 3178808438
• Email: iupdp[@]iupui.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder With Psychotic Features
• Disease
• Major Depression With Psychotic Features
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Program for Risk Evaluation and Prevention (PREP) - University of Michigan	Ann Arbor	Michigan
United States	The Early Psychosis Intervention Center (EPICENTER) at Ohio State	Columbus	Ohio
United States	Prevention and Recovery Center for Early Psychosis	Indianapolis	Indiana
United States	Vanderbilt's Early Psychosis Program - Vanderbilt University	Nashville	Tennessee
United States	Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University	New Orleans	Louisiana
United States	Strong Ties Young Adults Program- University of Rochester Medical Center	Rochester	New York

Sponsors (8)

Lead Sponsor	Collaborator
Indiana University	National Institute of Mental Health (NIMH), Ohio State University, Tulane University, University of Michigan, University of Rochester, Vanderbilt University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Number of participants hospitalized	Count of the number of participants hospitalized (adjusted for time in treatment)	12 months
Secondary	Time (days) to first hospitalization	Count of the time in days to first hospitalization	12 months
Secondary	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.	12 months