Coordinated Specialty Care for Psychosis

(AC-EPINET Trial)

No longer recruiting at 6 trial locations
AV
MG
RM
Overseen ByResearch Manager
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of delivering Coordinated Specialty Care (CSC) for individuals with psychosis. One group receives care in a clinic, while the other receives care through telehealth (online or phone-based services). The trial aims to determine which method better engages patients and improves their health outcomes over 12 months. Individuals who have experienced a non-affective or affective psychotic disorder (such as schizophrenia or bipolar disorder with psychotic features) within the last five years and can attend one of six specific clinical programs may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative care methods for psychosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for treating psychosis?

Research shows that Coordinated Specialty Care (CSC) is a safe and effective early treatment for individuals experiencing their first episode of psychosis. Studies have found that CSC reduces hospital visits and enhances success in school and work. It also alleviates symptoms and improves overall well-being.

This trial tests a telehealth version of CSC, which gained popularity during the pandemic. Research on telehealth CSC suggests it can be effective and implemented successfully. Although specific safety details for the telehealth version are not highlighted, the traditional CSC model is known for its safety, indicating the telehealth version is likely safe as well.

Since this trial is not in its early stages, major safety issues have likely been addressed. Participants can feel reassured knowing CSC has a strong history of safety and effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about the Coordinated Specialty Care (CSC) approaches for psychosis because they offer innovative ways to deliver mental health treatment. Unlike traditional in-person methods, the CSC-TH arm utilizes telehealth to provide care, making it more accessible for people who might struggle to get to a clinic. This could be a game-changer for those in remote areas or with transportation challenges. Both CSC models aim to offer a comprehensive treatment plan that integrates various services, potentially leading to more effective management of psychosis symptoms compared to conventional options.

What evidence suggests that this trial's treatments could be effective for psychosis?

Studies have shown that Coordinated Specialty Care (CSC) effectively supports individuals experiencing their first episode of psychosis. Research indicates that CSC can reduce hospital visits, improve job and school success, and decrease symptoms. In this trial, participants will receive either the standard clinic-based CSC model (CSC-SD) or the telehealth-based CSC model (CSC-TH). CSC-TH, the online version, offers the same benefits but is delivered over the internet, making access to care more convenient. Both standard CSC and CSC-TH aim to help individuals live healthier, more stable lives.13678

Who Is on the Research Team?

AB

Alan Breier

Principal Investigator

Indiana Univeristy

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 16 and 35 years old.
New intakes enrolled in one of the six clinical programs
Able to give informed consent
See 2 more

Exclusion Criteria

Known IQ < 70 based on participant report

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either telehealth-based or standard clinic-based CSC model treatment for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Coordinated Specialty Care (CSC)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSC-THExperimental Treatment1 Intervention
Group II: CSC-SDPlacebo Group1 Intervention

Coordinated Specialty Care (CSC) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Coordinated Specialty Care for:
🇪🇺
Approved in European Union as Coordinated Specialty Care for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Vanderbilt University

Collaborator

Trials
714
Recruited
6,143,000+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+

Tulane University

Collaborator

Trials
129
Recruited
259,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Northwestern University

Collaborator

Trials
1,674
Recruited
989,000+

Published Research Related to This Trial

Coordinated specialty care (CSC) is an evidence-based approach for treating individuals experiencing their first episode of psychosis, focusing on therapies that support both the client and their family.
The CSC model emphasizes building a therapeutic alliance and includes education and skills training to enhance recovery, improve quality of life, and help clients achieve their personal goals.
Evidence-Based Psychosocial Treatment for Individuals with Early Psychosis.Wright, A., Browne, J., Mueser, KT., et al.[2021]
Coordinated specialty care (CSC) models for first episode psychosis (FEP) have been developed to enhance recovery and prevent disability, but their growth is threatened by financial challenges in behavioral health policy.
The authors highlight the variability in CSC implementation across Ohio counties and provide recommendations to improve care quality and access for individuals with FEP, aiming to promote behavioral health equity.
Policy Complexities in Financing First Episode Psychosis Services: Implementation Realities from a Home Rule State.Moon, KJ., Stephenson, S., Hasenstab, KA., et al.[2023]
A study of 6,246 individuals with first-episode psychosis over an average follow-up of 4.24 years revealed significant gaps in the delivery of coordinated specialty care (CSC), particularly in the use and monitoring of antipsychotic medications.
Key quality indicators showed that inadequate monitoring for smoking and lack of integrated care were strongly linked to higher rates of psychiatric hospitalization, indicating that improvements in these areas are crucial for better patient outcomes.
Using Claims Data to Assess Treatment Quality of First-Episode Psychosis.Reist, C., Valdes, E., Ren, Y., et al.[2021]

Citations

Coordinated Specialty Care for First Episode PsychosisCoordinated Specialty Care (CSC) is a multi- component, evidence-based, early intervention service for individuals experiencing a first episode.
Scaling Coordinated Specialty Care for First-Episode ...While every experience with FEP is unique, research shows the significant impact that psychosis can have on health, employment, housing, and ...
The Academic Community Early Psychosis Intervention ...Compared to usual care, specialty services for first‐episode psychosis (FES) have superior patient outcomes. The Early Psychosis Intervention ...
A Needs Assessment of Ohio Community Mental Health CentersCoordinated specialty care (CSC) is considered the gold-standard treatment for individuals experiencing first episode psychosis (FEP).
Coverage of Coordinated Specialty Care (CSC) for Early or ...When compared with other care for psychosis, CSC is more effective at reducing hospitalizations, improving education and employment rates, reducing symptoms and ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36449475/
Telehealth of Coordinated Specialty Care in Early ...The ongoing pandemic offers the opportunity to review the feasibility of EP services using telehealth and to evaluate implications for continued implementation.
Implementation of Coordinated Specialty Services for First ...Coordinated Specialty Care (CSC) is an evidence based approach to providing early intervention for psychosis, and it has been found.
Workforce Development In Coordinated Specialty Care ...Research also has demonstrated that reducing the duration of untreated psychosis (DUP) results in better long-term outcomes, such as higher rates of recovery ...
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