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NCT06071858Recruiting

Enhanced Coordinated Specialty Care for Early Psychosis

Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
350 (estimated)
First submitted
26 Sept 2023
Start date
1 Feb 2024
Primary completion date
Oct 2028
Lead sponsor
Mclean Hospital
NCT number
NCT06071858

What you commit to

  • Study type: Interventional
  • Planned participants: 350
  • From 1 Feb 2024 to the primary completion date, Oct 2028
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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)

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McLean Hospital OnTrack Clinic
Coordinator of this site? Confirm its status
BelmontUnited StatesRecruiting
Massachusetts General Hospital FEPP Clinic
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Boston Medical Center WRAP
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Cambridge Health Alliance RISE Clinic
Coordinator of this site? Confirm its status
CambridgeUnited StatesRecruiting
UMass Memorial Community Healthlink STEP Clinic
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.