SchizophreniaAC-EPINETNCT04497857
Academic-Community EPINET (AC-EPINET)
A study testing Coordinated Specialty Care (CSC) in people with Schizophrenia and Schizoaffective Disorder, run by Indiana University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- What is being tested?
- Coordinated Specialty Care (CSC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Mar 2022to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 1. Known IQ < 70 based on participant report
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Program for Risk Evaluation and Prevention (PREP) - University of Michigan
Ann Arbor, Michigan, 48109
The Early Psychosis Intervention Center (EPICENTER) at Ohio State
Columbus, Ohio, 43210
Prevention and Recovery Center for Early Psychosis
Indianapolis, Indiana, 46202
Vanderbilt's Early Psychosis Program - Vanderbilt University
Nashville, Tennessee, 37212
Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University
New Orleans, Louisiana, 70119
Strong Ties Young Adults Program- University of Rochester Medical Center
Rochester, New York, 14623
About this study
Official title: Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
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.
Read the detailed description
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
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Major Depression With Psychotic Features, Bipolar Disorder With Psychotic Features
- Being tested
- Coordinated Specialty Care (CSC)
- Keywords
- psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated Specialty Care (CSC)Other
CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders
| Study group | Role | What they receive |
|---|---|---|
| CSC-SD | Placebo comparator | Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months. Receives: Other: Coordinated Specialty Care (CSC) |
| CSC-TH | Experimental | Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months. Receives: Other: Coordinated Specialty Care (CSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
Number of participants hospitalized
Count of the number of participants hospitalized (adjusted for time in treatment)
Measured: 12 months
Time (days) to first hospitalization
Count of the time in days to first hospitalization
Measured: 12 months
Symptom outcomes assessed by the Modified Colorado Symptom Index (MCSI)
The modified Colorado Symptom Index (MCSI) is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms in psychosis. Items are rated on a 5-point Likert-style scale (Not at all, Once during the month, Several times during the month, Several times a week, at least every day). Each item is scored on a 0-4 scale (not at all = 0; at least every day = 4) and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress.
Measured: 12 months
Symptom outcomes assessed by the COMPASS-10
The COMPASS10 consists of 10 items selected from the COMPASS scale developed for the RAISE ETP study. The COMPASS-10 is a clinician-rated assessment of symptom severity in psychosis. There are 10 items measuring anxiety, asociality, avolition, depression, disorganization, hallucinations, hostility, suicidal ideation or behavior, suspiciousness and unusual thought content. The items are rated on a Likert scale from 0 to 6 (0 = not present, 1 =very mild, 2 = mild, 3 = moderate 4= moderately severe, 5 = severe, 6= very severe), with higher scores indicating increased severity of symptoms. For each item, assessors provide ratings of symptom severity after sufficient information is obtained through probe questions.
Measured: 12 months
Functioning outcomes assessed by the MIRECC-GAF
The MIRECC GAF ( Mental Illness Research, Education, and Clinical Center Global Assessment of Functioning) 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start16 Mar 2022
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Ohio State University, Vanderbilt University, Tulane University, University of Rochester, Yale University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alan Breier, Indiana University
- Investigators
- Alan Breier, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497857
- Sponsor's protocol ID
- epinet
- Other IDs
- 5R01MH120588-02
- Acronym
- AC-EPINET
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
- ClinicalTrials.gov ID
- NCT04497857
- Acronym / sponsor ID
- AC-EPINET / epinet
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Major Depression With Psychotic Features, Bipolar Disorder With Psychotic Features
- Keywords
- psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Ohio State University, Vanderbilt University, Tulane University, University of Rochester, Yale University, National Institute of Mental Health (NIMH)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSC-SD | Placebo comparator | Other: Coordinated Specialty Care (CSC)Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months. |
| CSC-TH | Experimental | Other: Coordinated Specialty Care (CSC)Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Known IQ < 70 based on participant report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coordinated Specialty Care (CSC)CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders | Other | CSC-SD, CSC-TH |
Primary outcome
Annualized hospitalization rates
Time frame: 12 months
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
5 secondary outcomes
Number of participants hospitalized
Time frame: 12 months
Time (days) to first hospitalization
Time frame: 12 months
Symptom outcomes assessed by the Modified Colorado Symptom Index (MCSI)
Time frame: 12 months
Symptom outcomes assessed by the COMPASS-10
Time frame: 12 months
Functioning outcomes assessed by the MIRECC-GAF
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Breier principal investigator
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated Specialty Care (CSC) in people with Schizophrenia and Schizoaffective Disorder, run by Indiana University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized hospitalization rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.