Skip to main content
Clinical Trials/NCT06071858
NCT06071858
Recruiting
N/A

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

Mclean Hospital5 sites in 1 country350 target enrollmentFebruary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosis
Sponsor
Mclean Hospital
Enrollment
350
Locations
5
Primary Endpoint
Months Engaged in Care
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
October 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dost Ongur

Director, LEAP Center

Mclean Hospital

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

Months Engaged in Care

Time Frame: 12 months following clinic intake

Number of months each participant had ≥4 visits in a 12-month period

Secondary Outcomes

  • Duration of Treatment(Up to 12 months - measured as time between clinic intake and detachment)
  • Clinic Visit Number(12 months following clinic intake)
  • Proportion in Arm Still in Clinic(12 months following clinic intake)
  • Clinic Visit Type(12 months following clinic intake)

Study Sites (5)

Loading locations...

Similar Trials