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Enhanced Coordinated Specialty Care for Early Psychosis

StatusRecruiting
PhaseNot applicable
Started2024-02-01
View on ClinicalTrials.gov ↗

Amendment history

2026-02-25
minor
Study Status, Oversight, IPDSharing v7
Re-verified, no change to tracked fields
2025-02-20
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 5 sites
2025-02-05
minor
Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations, IPDSharing v5
Study sites6→5
Collaborators6 to 5 entries
ServiceNet, Springfield
2024-02-07
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03-15→confirmed 2024-02-01
Study sites0→6
2024-02-05
minor
Study Status v3
Start date2024-01-15→2024-03-15
Show 2 earlier versions
2024-01-05
minor
Study Status v2
Start date2023-10→2024-01-15
2023-10-06
minor
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2023-10-03
minor
Original filing
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.
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