Enhanced care for early psychosis treatment
Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
NA · Mclean Hospital · NCT06071858
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Sex | All |
| Sponsor | Mclean Hospital (other) |
| Locations | 5 sites (Belmont, Massachusetts and 4 other locations) |
| Trial ID | NCT06071858 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing an intake evaluation for first-episode psychosis at designated outpatient clinics in Massachusetts.
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.
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 performed: Other studies have shown promising results with coordinated specialty care approaches, suggesting potential for success with this enhanced model.
Eligibility criteria
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 this trial is running
Belmont, Massachusetts and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychosis, Schizophrenia, Schizoaffective Disorder, Psychosis Nos/Other, Bipolar Disorder, first episode psychosis, early psychosis