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Coordinated Specialty Care for Psychosis (AC-EPINET Trial)

N/A
Recruiting
Led By Alan Breier
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 16 and 35 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months

Summary

This trial will compare the effects of two types of cancer support services on engagement and outcomes.

Who is the study for?
This trial is for young individuals aged 16-35 who have recently been diagnosed with certain mental health conditions, including schizophrenia and bipolar disorder with psychotic features. Participants must be new to one of the six clinical programs, able to consent, and commit to the study schedule.
What is being tested?
The study compares two ways of delivering Coordinated Specialty Care (CSC) for mental health: through telehealth (CSC-TH) versus standard in-clinic care (CSC-SD). The goal is to see which method keeps patients more engaged over a year.
What are the potential side effects?
Since this trial focuses on service delivery methods rather than medication, side effects are not typical as seen with drug trials. However, participants may experience varying levels of comfort or satisfaction with the mode of therapy they receive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 16 and 35 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized hospitalization rates
Secondary study objectives
Number of participants hospitalized
Symptom and functioning outcomes assessed by the MIRECC-GAF
Time (days) to first hospitalization

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSC-THExperimental Treatment1 Intervention
Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
Group II: CSC-SDPlacebo Group1 Intervention
Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,200 Total Patients Enrolled
9 Trials studying Schizophrenia
1,675 Patients Enrolled for Schizophrenia
University of RochesterOTHER
872 Previous Clinical Trials
549,731 Total Patients Enrolled
1 Trials studying Schizophrenia
79 Patients Enrolled for Schizophrenia
University of MichiganOTHER
1,862 Previous Clinical Trials
6,441,287 Total Patients Enrolled
6 Trials studying Schizophrenia
524 Patients Enrolled for Schizophrenia
Indiana UniversityLead Sponsor
1,043 Previous Clinical Trials
1,316,665 Total Patients Enrolled
14 Trials studying Schizophrenia
837 Patients Enrolled for Schizophrenia
Yale UniversityOTHER
1,930 Previous Clinical Trials
3,033,264 Total Patients Enrolled
60 Trials studying Schizophrenia
4,159 Patients Enrolled for Schizophrenia
Ohio State UniversityOTHER
871 Previous Clinical Trials
655,792 Total Patients Enrolled
2 Trials studying Schizophrenia
160 Patients Enrolled for Schizophrenia
Tulane UniversityOTHER
123 Previous Clinical Trials
239,280 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,933 Previous Clinical Trials
2,745,858 Total Patients Enrolled
255 Trials studying Schizophrenia
90,171 Patients Enrolled for Schizophrenia
Northwestern UniversityOTHER
1,652 Previous Clinical Trials
961,335 Total Patients Enrolled
11 Trials studying Schizophrenia
1,965 Patients Enrolled for Schizophrenia
Alan BreierPrincipal InvestigatorIndiana Univeristy

Media Library

Coordinated Specialty Care (CSC) Clinical Trial Eligibility Overview. Trial Name: NCT04497857 — N/A
Schizophrenia Research Study Groups: CSC-SD, CSC-TH
Schizophrenia Clinical Trial 2023: Coordinated Specialty Care (CSC) Highlights & Side Effects. Trial Name: NCT04497857 — N/A
Coordinated Specialty Care (CSC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497857 — N/A
~35 spots leftby Aug 2025
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