Enhanced Care for Psychosis

Recruiting at 5 trial locations

Overseen By Jacqueline Dow, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding extra care elements to standard treatment encourages people with first-episode psychosis to visit the clinic more frequently. Participants will receive either the usual care or the usual care plus five additional supports, such as peer help and digital outreach. The goal is to determine if these supports improve treatment engagement. Individuals beginning treatment for first-episode psychosis at specific outpatient clinics in Massachusetts may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance treatment engagement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these care elements are safe for first-episode psychosis?

Research has shown that Coordinated Specialty Care (CSC) is generally safe and well-received by individuals experiencing early psychosis. CSC, a team-based approach, aids recovery, enhances quality of life, and reduces symptoms. Enhanced Coordinated Specialty Care (CSC 2.0) offers additional support, including peer support, digital outreach, and family therapy.

No specific safety concerns have been reported for CSC 2.0. Since the core components of CSC have been used successfully for years, the added features in CSC 2.0 are likely safe, as they build on proven methods. Overall, CSC and its enhanced version aim to provide supportive and effective care for those experiencing their first episode of psychosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced Coordinated Specialty Care (CSC 2.0) for psychosis because it builds on the standard care with several innovative components. Unlike typical treatments that focus on medication and standard therapy alone, CSC 2.0 includes 1:1 peer support and digital outreach, which can provide continuous, personalized engagement and support. It also offers multi-family group therapy and cognitive remediation, addressing both social and cognitive aspects of recovery, which are often overlooked. These enhancements aim to create a more comprehensive support system, potentially improving outcomes for individuals with psychosis.

What evidence suggests that Enhanced Coordinated Specialty Care (CSC 2.0) is effective for increasing treatment engagement in first-episode psychosis?

Research has shown that Coordinated Specialty Care (CSC) helps individuals experiencing their first episode of psychosis. This approach supports recovery, reduces symptoms, and improves quality of life. In this trial, one group will receive the updated version, CSC 2.0, which includes peer support, digital outreach, care coordination, group therapy for families, and cognitive exercises. These additions aim to keep participants engaged in their treatment. Evidence suggests that this comprehensive care can offer better support and lead to more regular treatment visits. ^{2 4 6 7 8}

Who Is on the Research Team?

Dost Ongur, MD, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for individuals experiencing their first episode of psychosis, which could be related to conditions like schizophrenia or bipolar disorder. Participants must be receiving care at specific clinics in Massachusetts and are excluded if they don't attend these clinics.

Inclusion Criteria

People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics: McLean Hospital OnTrack (OnTrack Clinic), Massachusetts General Hospital (FEPP Clinic), Boston Medical Center (WRAP Clinic), Cambridge Health Alliance (RISE Clinic), UMass Memorial Health Care (STEP Clinic), ServiceNet (PREP West)

You are enrolled in McLean Hospital's OnTrack program.

You are receiving care from the FEPP Clinic at Massachusetts General Hospital.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard coordinated specialty care (CSC) or enhanced care (CSC 2.0) with additional elements such as peer support and digital outreach

12 months

Multiple visits (in-person and virtual) as part of CSC or CSC 2.0

Follow-up

Participants are monitored for engagement and outcomes after the initial treatment period

12 months

Extension

Exploratory analysis of symptom and functioning measures over an extended period

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Coordinated Specialty Care

Trial Overview The study compares standard coordinated specialty care (CSC) with an enhanced version (CSC 2.0), which adds individual peer support, digital outreach, extra care coordination, multi-family group therapy, and cognitive remediation to see if it increases clinic visits.

How Is the Trial Designed?

Group I: Enhanced Coordinated Speciality Care (CSC 2.0) Experimental Treatment 5 Interventions

CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).

Group II: Coordinated Specialty Care (CSC; standard of care) Active Control 1 Intervention

Care as usual; no intervention.

Enhanced Coordinated Specialty Care is already approved in United States for the following indications:

Approved in United States as Coordinated Specialty Care for:

• First-episode psychosis
• Early psychosis
• Schizophrenia

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

ServiceNet, Springfield

Collaborator

Trials

1

Recruited

350+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Cambridge Health Alliance

Collaborator

Trials

65

Recruited

22,400+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Published Research Related to This Trial

A study of 287 patients in Massachusetts receiving coordinated specialty care (CSC) for early intervention in psychotic disorders showed significant improvements in functioning and symptom management after 6 and 12 months of treatment.

The findings highlight the effectiveness of CSC programs in enhancing patient outcomes, although challenges with data collection and variability between clinics were noted, suggesting a need for better strategies in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Real-world" first-episode psychosis care in Massachusetts: Lessons learned from a pilot implementation of harmonized data collection. Kline, ER., Johnson, KA., Szmulewicz, A., et al.[2023]

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]

Coordinated specialty care (CSC) is an effective treatment approach for individuals at the onset of schizophrenia, supported by increased federal funding for community mental health programs.

The National Institute of Mental Health has developed 19 new clinical measures to assess various aspects of early psychosis, which aim to improve routine clinical practices and address challenges in data collection at nonacademic sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations and Challenges of the Clinical Services Panel of the PhenX Early Psychosis Working Group. Dixon, L., Jones, N., Loewy, R., et al.[2020]

Coordinated Specialty Care (CSC) has rapidly expanded in the U.S. from 12 programs in 2008 to over 160 by 2018, providing multidisciplinary support for young adults experiencing their first episode of psychosis.

Despite the growth of CSC programs, there are ongoing debates about how closely these programs adhere to the original CSC models and a lack of clear evidence on which core components are essential for achieving positive outcomes for clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The History of Coordinated Specialty Care for Early Intervention in Psychosis in the United States: A Review of Effectiveness, Implementation, and Fidelity. Read, H., Kohrt, BA.[2022]

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]

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]

The financing for coordinated specialty care (CSC) for first-episode psychosis is inconsistent and primarily relies on fee-for-service insurance billing, which does not align well with the goals of CSC, potentially threatening its sustainability.

Stakeholders in CSC programs advocate for a bundled-payment model that ties payments to client outcomes, emphasizing the need for collaboration between payers and providers to create a funding approach that supports the diverse needs of CSC programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financing Early Psychosis Intervention Programs: Provider Organization Perspectives. Bao, Y., Papp, MA., Lee, R., et al.[2023]

A comprehensive analysis of 66 interviews with providers and 82 clients from 36 coordinated specialty care (CSC) sites revealed significant variability in discharge practices and concerns about postdischarge service accessibility.

Both clinicians and clients expressed worries about discharge readiness and the adequacy of support after leaving CSC programs, indicating a need for improved guidelines and potential adjustments to the current time-limited CSC model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinated Specialty Care Discharge, Transition, and Step-Down Policies, Practices, and Concerns: Staff and Client Perspectives. Jones, N., Gius, B., Daley, T., et al.[2021]

In a study involving 47 participants over 12 months, Coordinated Specialty Care (CSC) showed promising engagement, with an average of 55 hours of service participation, including clinical, psychiatric, vocational, and family services.

The outcomes were positive, with 83% of participants either employed or in school and 72% avoiding psychiatric hospitalization, indicating that CSC can effectively support individuals with recent onset psychosis in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating and sustaining Coordinated Specialty Care for a recent onset of psychosis in non-academic-affiliated community mental healthcare settings. Klodnick, VV., Brenits, A., Johnson, RP., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11179455

Project Details The CSC 2.0 intervention includes peer providers, digital outreach, family groups, coordination with ED/inpatient providers/PCPs, and cognitive remediation, all ...

2. psychiatrictimes.com psychiatrictimes.com/view/coordinated-specialty-care-paving-the-way-for-psychosis-recovery

Coordinated Specialty Care: Paving the Way for Psychosis ... Early intervention in schizophrenia enhances recovery, reduces symptoms, and improves quality of life through coordinated specialty care programs across the US.

3. withpower.com withpower.com/trial/enhanced-care-for-psychosis-1f0e9

Enhanced Care for Psychosis The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in ...

4. nami.org nami.org/wp-content/uploads/2024/11/Scaling-CSC-for-FEP-Insights-from-a-National-Impact-Model.pdf

Scaling Coordinated Specialty Care for First-Episode ... Over 10 years, expanding access to CSC from the baseline rate of 10%–25% to a rate of 90% could provide evidence-based care for approximately ...

5. formative.jmir.org formative.jmir.org/2023/1/e46491/

Implementation Outcomes From a Development and Usability ... Coordinated specialty care (CSC) has demonstrated efficacy in improving outcomes in individuals at clinical high risk for psychosis and ...

6. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11179455

Project Details - NIH RePORTER The CSC 2.0 intervention includes peer providers, digital outreach, family groups, coordination with ED/inpatient providers/PCPs, and cognitive remediation, all ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582803/

Implementing Technologies to Enhance Coordinated ... Coordinated specialty care (CSC) has demonstrated efficacy in improving outcomes in individuals at clinical high risk for psychosis and individuals with ...

8. nri-inc.org nri-inc.org/media/1591/nri_workforce_development_csc.pdf

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 ...