Clinical trial Recruiting at 5 sites Interventional

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 typeInterventional
SexAll
Enrollment350 (estimated)
SponsorMclean Hospital
Academic / other
Locations5 sites (Belmont, Massachusetts and 4 other locations)
StatusRecruiting
StartedFebruary 1, 2024
Main results expectedOctober 2028
Study endsOctober 2028
Registry record updatedFebruary 27, 2026
Trial IDNCT06071858 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.