Clinical Trial

Enhanced Coordinated Specialty Care for Early Psychosis

Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-10-03; most recent amendment 2026-02-25.
Status change: Not Yet Recruiting → Recruiting 2024-02-07
Trial Details
NCT Number NCT06071858
Lead Sponsor Mclean Hospital
Collaborators: Massachusetts General Hospital, Boston Medical Center, Cambridge Health Alliance, University of Massachusetts, Worcester, National Institute of Mental Health (NIMH)
Conditions Psychosis, Schizophrenia, Schizoaffective Disorder, Psychosis Nos/Other, Bipolar Disorder
Enrollment 350 participants
Start Date 2024-02-01
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-27