Enhanced care for early psychosis treatment
Official title: Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
Run by Mclean Hospital · NCT06071858 · Data updated 2026-11-12
This study is testing whether a new, more supportive treatment for people experiencing their first episode of psychosis helps them stay engaged in their care better than standard treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 5 sites (Belmont, Massachusetts and 4 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06071858 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals undergoing an intake evaluation for first-episode psychosis at designated outpatient clinics in Massachusetts.
✕Probably not a fit
Patients who are not experiencing first-episode psychosis or those who do not meet the intake evaluation criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of enhanced coordinated specialty care (CSC 2.0) compared to standard CSC for individuals experiencing first-episode psychosis. Participants will either receive standard care or an enhanced version that includes additional support elements such as individual peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation. The primary focus is to determine if these additional elements lead to increased engagement in treatment, measured by the number of clinic visits in the first year. The study will take place across several outpatient clinics in Massachusetts.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment engagement and outcomes for patients experiencing early psychosis.
How similar studies have gone: Other studies have shown promising results with coordinated specialty care approaches, suggesting potential for success with this enhanced model.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * None
Where it's running
-
McLean Hospital OnTrack Clinic
Belmont, Massachusetts, United States Recruiting -
Massachusetts General Hospital FEPP Clinic
Boston, Massachusetts, United States Recruiting -
Boston Medical Center WRAP
Boston, Massachusetts, United States Recruiting -
Cambridge Health Alliance RISE Clinic
Cambridge, Massachusetts, United States Recruiting -
UMass Memorial Community Healthlink STEP Clinic
Worcester, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Dost Ongur, MD, PhD — Mclean Hospital
- Study coordinator: Dost Ongur, MD, PhD
- Email: dongur@mgb.org
- Phone: 617-855-3922
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.