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Enhanced Coordinated Specialty Care for Early Psychosis
NCT06071858 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Care Coordination
- BEHAVIORAL Individual Peer Support
- BEHAVIORAL Digital Outreach
- BEHAVIORAL Cognitive Remediation
- BEHAVIORAL Multi-Family Group Therapy
Study Locations (5)
Massachusetts
- McLean Hospital OnTrack Clinic — Belmont
- Massachusetts General Hospital FEPP Clinic — Boston
- Boston Medical Center WRAP — Boston
- Cambridge Health Alliance RISE Clinic — Cambridge
- UMass Memorial Community Healthlink STEP Clinic — Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2028-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06071858
The ClinicalTrials.gov registry entry for NCT06071858 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 160 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Schizophrenia appearing as the primary indexed condition, and to 5 interventions — of which Care Coordination is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06071858 reports 5 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06071858 about?
NCT06071858 is a clinical study titled "Enhanced Coordinated Specialty Care for Early 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 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 treatm...
What is the current status of trial NCT06071858?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2024-02-01. Estimated completion is 2028-10.
What conditions does trial NCT06071858 study?
This clinical trial studies the following conditions: Schizophrenia, Bipolar Disorder, Schizoaffective Disorder, Psychosis, Psychosis Nos/Other. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06071858?
The interventions under investigation include: Care Coordination (BEHAVIORAL), Individual Peer Support (BEHAVIORAL), Digital Outreach (BEHAVIORAL), Cognitive Remediation (BEHAVIORAL), Multi-Family Group Therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06071858?
This trial is sponsored by Mclean Hospital, which has 160 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06071858 being conducted?
This trial has 5 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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