Coordinated Specialty Care for Psychosis

(AC-EPINET Trial)

Recruiting at 6 trial locations

Overseen By Research Manager

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: IQ < 70

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

180 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Coordinated Specialty Care (CSC) for First Episode Psychosis (FEP)?

Research shows that Coordinated Specialty Care (CSC) is an effective treatment for people experiencing their first episode of psychosis. It helps improve recovery and quality of life by providing group, individual, and family therapies that focus on understanding and coping with psychosis, as well as building skills like problem-solving and communication. ^{1 2 3 4 5}

Is Coordinated Specialty Care for psychosis safe for humans?

The research articles reviewed do not provide specific safety data for Coordinated Specialty Care (CSC) for psychosis, but they do indicate that CSC is a widely accepted and standard practice for treating first-episode psychosis, suggesting it is generally considered safe. ^{2 3 4 5 6}

How is the treatment Coordinated Specialty Care (CSC) for psychosis different from other treatments?

Coordinated Specialty Care (CSC) is unique because it is a team-based approach that combines group, individual, and family therapies to help people with early psychosis. It focuses on building a supportive relationship, recovery, education, and skills training to improve quality of life and help patients achieve personal goals. ^{2 3 4 5 7}

What is the purpose of this trial?

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.

Research Team

Alan Breier

Principal Investigator

Indiana Univeristy

Eligibility Criteria

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

Exclusion Criteria

Known IQ < 70 based on participant report

Timeline

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

Treatment Details

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.

Participant Groups

Group I: CSC-TH Experimental Treatment 1 Intervention

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

Group II: CSC-SD Placebo Group 1 Intervention

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

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:

• First episode psychosis
• Psychotic disorders

Approved in European Union as Coordinated Specialty Care for:

• First episode psychosis
• Psychotic disorders

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+

Findings from Research

A machine-learning prediction tool was developed to forecast education and work outcomes for individuals aged 16 to 30 with first-episode psychosis, showing strong predictive accuracy with AUCs ranging from 0.68 to 0.88 for one-year trajectories.

While the tool effectively predicts education/work status, it struggled with forecasting psychiatric hospitalizations beyond three months, indicating a need for further development in this area before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction Tool for Individual Outcome Trajectories Across the Next Year in First-Episode Psychosis in Coordinated Specialty Care. Basaraba, CN., Scodes, JM., Dambreville, R., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Claims Data to Assess Treatment Quality of First-Episode Psychosis. Reist, C., Valdes, E., Ren, Y., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Psychosocial Treatment for Individuals with Early Psychosis. Wright, A., Browne, J., Mueser, KT., et al.[2021]

Specialized early interventions (SEI), particularly Coordinated Specialty Care (CSC) programs, are effective in improving functional and clinical outcomes for individuals experiencing their first episode of psychosis, as supported by existing literature.

Despite their effectiveness, CSC programs face significant barriers to implementation, including stigma, cultural competence issues, and challenges in rural areas, which need to be addressed to enhance their success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Coordinated Specialty Care for First Episode Psychosis: A Review of Barriers and Solutions. Powell, AL., Hinger, C., Marshall-Lee, ED., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Policy Complexities in Financing First Episode Psychosis Services: Implementation Realities from a Home Rule State. Moon, KJ., Stephenson, S., Hasenstab, KA., et al.[2023]

In a study involving 697 participants from nine Pennsylvania Coordinated Specialty Care (CSC) programs, significant improvements were observed in symptoms, social functioning, and self-perceived recovery after 12 months of treatment for first-episode psychosis.

The results indicate that the PA FEP CSC programs are effective in reducing symptoms and improving quality of life, with most improvements noted at the 6-month follow-up and maintained at 12 months, supporting the continuation of these programs to help individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pennsylvania coordinated specialty care programs for first-episode psychosis: 6- and 12-month outcomes. Westfall, MBE., Kohler, CG., Hurford, I., et al.[2021]

A study of 34 Coordinated Specialty Care (CSC) programs across 22 U.S. states found that 59% of these programs heavily relied on Mental Health Block Grant (MHBG) set-aside funds for their financing, with some programs depending on these funds for over 75% of their total budget.

Programs that were newer (≤5 years old) were more likely to depend on MHBG funds, while those in Medicaid expansion states had better access to Medicaid funding, indicating that community and program characteristics significantly influence funding sources for CSC services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community- and Program-Level Predictors of Funding Streams Used by Coordinated Specialty Care Programs. Ghose, SS., George, P., Goldman, HH., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prediction Tool for Individual Outcome Trajectories Across the Next Year in First-Episode Psychosis in Coordinated Specialty Care. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Using Claims Data to Assess Treatment Quality of First-Episode Psychosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-Based Psychosocial Treatment for Individuals with Early Psychosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implementing Coordinated Specialty Care for First Episode Psychosis: A Review of Barriers and Solutions. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Policy Complexities in Financing First Episode Psychosis Services: Implementation Realities from a Home Rule State. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Pennsylvania coordinated specialty care programs for first-episode psychosis: 6- and 12-month outcomes. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Community- and Program-Level Predictors of Funding Streams Used by Coordinated Specialty Care Programs. [2023]