Enhanced Care for Psychosis
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mclean Hospital
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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 first-episode psychosis. The main question it aims to answer is:
• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?
Participants will either:
* Receive care as usual (CSC) or
* Receive care as usual (CSC) plus five additional care elements (CSC 2.0):
1. Individual peer support
2. Digital outreach
3. Care coordination
4. Multi-family group therapy
5. Cognitive remediation
Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.
How is Enhanced Coordinated Specialty Care different from other treatments for psychosis?
Enhanced Coordinated Specialty Care (CSC) is unique because it uses a team-based approach to support young adults experiencing their first episode of psychosis, focusing on early intervention to improve outcomes. This model has rapidly expanded in the U.S. due to its effectiveness, although challenges remain in maintaining consistent quality across programs.
34569Is Enhanced Care for Psychosis safe for humans?
The research articles reviewed do not provide specific safety data for Enhanced Care for Psychosis or its related programs like Coordinated Specialty Care (CSC). They focus on the implementation, effectiveness, and challenges of these programs rather than safety outcomes.
12368What data supports the effectiveness of the treatment Enhanced Coordinated Specialty Care for psychosis?
Research shows that Coordinated Specialty Care (CSC) is widely used for early intervention in psychosis and has expanded significantly in the U.S. due to its effectiveness. Studies highlight its value in improving care for first-episode psychosis, suggesting that Enhanced CSC could further enhance these benefits.
23567Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Eligibility Criteria
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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Coordinated Speciality Care (CSC 2.0)Experimental Treatment5 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 Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
McLean Hospital OnTrack ClinicBelmont, MA
Massachusetts General Hospital FEPP ClinicBoston, MA
Cambridge Health Alliance RISE ClinicCambridge, MA
Boston Medical Center WRAPBoston, MA
More Trial Locations
Loading ...
Who is running the clinical trial?
Mclean HospitalLead Sponsor
Massachusetts General HospitalCollaborator
National Institute of Mental Health (NIMH)Collaborator
ServiceNet, SpringfieldCollaborator
Boston Medical CenterCollaborator
Cambridge Health AllianceCollaborator
University of Massachusetts, WorcesterCollaborator
References
Recommendations and Challenges of the Clinical Services Panel of the PhenX Early Psychosis Working Group. [2020]Coordinated specialty care (CSC) is a promising multielement treatment for the care of individuals experiencing the onset of schizophrenia. The community mental health block grant program has increased federal support for CSC programs. In order to maximize the number of sites capable of science-to-service or service-to-science translation, the National Institute of Mental Health funded a supplement to the PhenX toolkit consisting of measures for early psychosis. The early psychosis working group included translational research and clinical services panels. The clinical services panel was charged with identifying low-burden and psychometrically sound measures for use in routine clinical settings. The 19 new clinical measures complement existing measures already in the toolkit. Measures cover a range of domains, including symptoms, social and occupational functioning, well-being, medication adherence and side effects, physical activity, and shared decision making and person-centered care. Several challenges are also discussed. The review process underscored the challenges facing nonacademic sites in collecting even low-burden assessments.
Coordinated Specialty Care Discharge, Transition, and Step-Down Policies, Practices, and Concerns: Staff and Client Perspectives. [2021]In recent years, optimizing the process of transition and discharge from coordinated specialty care (CSC), a program that provides early intervention in psychosis, has emerged as an important focus area for program administrators, clinicians, and policy makers. To explore existing CSC policies and practices and to understand frontline provider and client views on discharge, the authors conducted a comprehensive analysis of staff and client interview data from the Mental Health Block Grant 10% Set-Aside Study.
Using Claims Data to Assess Treatment Quality of First-Episode Psychosis. [2021]Coordinated specialty care (CSC) has become the standard of care for first-episode psychosis (FEP). The gap between CSC best practices and the actual care delivered is unknown. This longitudinal study aimed to measure that gap by using a large Medicaid claims database and 10 quality indicators (QIs) reflecting aspects of CSC and to study the relationship between these QIs and future health care utilization.
Financing Early Psychosis Intervention Programs: Provider Organization Perspectives. [2023]The authors aimed to identify prominent financing approaches for coordinated specialty care (CSC) of patients with first-episode psychosis, alignment or misalignment of such approaches with sustained CSC implementation, and CSC provider perspectives on ideal payment models.
"Real-world" first-episode psychosis care in Massachusetts: Lessons learned from a pilot implementation of harmonized data collection. [2023]Increasing evidence points to the value of coordinated specialty care (CSC) for early intervention in psychotic disorders. This report characterizes clinical and socio-demographic features of patients at CSC programs in Massachusetts (MA), assessed by a standardized battery incorporated into "real-world" clinical care.
The History of Coordinated Specialty Care for Early Intervention in Psychosis in the United States: A Review of Effectiveness, Implementation, and Fidelity. [2022]Coordinated Specialty Care (CSC) is a multidisciplinary team approach to providing care for young and emerging adults having their first episode of psychosis. CSC programs have expanded rapidly throughout the United States going from 12 programs in 2008 to over 160 programs a decade later. The purpose of this historical review is to document the process and conditions that led to the accelerated dissemination of these programs across the country. CSC models began in the US in the early 2000s, but nationwide expansion followed the 2008 Recovery After an Initial Schizophrenia Episode trial. As programs have grown, debates have risen about fidelity to CSC models. The challenges facing CSC programs today include lack of evidence on what are the core components of CSC and how fidelity monitoring relates to positive client outcomes.
Prediction Tool for Individual Outcome Trajectories Across the Next Year in First-Episode Psychosis in Coordinated Specialty Care. [2023]In coordinated specialty care (CSC) settings for people with a first episode of psychosis, the development of reliable, validated individual-level prediction tools for key outcomes may be informative for shared clinician and client decision-making.
Evaluating and sustaining Coordinated Specialty Care for a recent onset of psychosis in non-academic-affiliated community mental healthcare settings. [2023]To improve sustainability of Coordinated Specialty Care (CSC) for a recent onset of psychosis, a better understanding is needed regarding how non-academic-affiliated community mental health centers blend CSC service elements and select key performance metrics to evaluate their approach.
Community- and Program-Level Predictors of Funding Streams Used by Coordinated Specialty Care Programs. [2023]Although coordinated specialty care (CSC) is an effective service model to address first-episode psychosis, CSC is not widely accessible in the United States, and funding for this service model often remains challenging. The authors examined whether community- or program-level factors predict the use of public and private funding streams in a national sample of 34 CSC programs in 22 U.S. states and territories.