Schizophrenia Clinical Trial
Official title:
Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
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 | Recruiting |
Enrollment | 350 |
Est. completion date | October 2028 |
Est. primary completion date | October 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital OnTrack Clinic | Belmont | Massachusetts |
United States | Boston Medical Center WRAP | Boston | Massachusetts |
United States | Massachusetts General Hospital FEPP Clinic | Boston | Massachusetts |
United States | Cambridge Health Alliance RISE Clinic | Cambridge | Massachusetts |
United States | ServiceNet PREP West | Holyoke | Massachusetts |
United States | UMass Memorial Community Healthlink STEP Clinic | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | Boston Medical Center, Cambridge Health Alliance, Massachusetts General Hospital, National Institute of Mental Health (NIMH), ServiceNet, Springfield, University of Massachusetts, Worcester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB) | Exploratory analysis of variables collected by EPINET CAB by arm | 12 months following clinic intake | |
Other | Proportion of Early Detachment | Proportion of patients in each arm who detach from clinic prior to the end of their first month in care | 1 month | |
Other | Months Engaged in Care - extension of primary outcome | Number of months each participant had =4 visits in a 24-month period | 24 months | |
Primary | Months Engaged in Care | Number of months each participant had =4 visits in a 12-month period | 12 months following clinic intake | |
Secondary | Clinic Visit Number | Total number of clinic visits in a 12-month period | 12 months following clinic intake | |
Secondary | Clinic Visit Type | Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period | 12 months following clinic intake | |
Secondary | Duration of Treatment | Duration of time in treatment | Up to 12 months - measured as time between clinic intake and detachment | |
Secondary | Proportion in Arm Still in Clinic | Proportion of patients in each arm who are still in CSC at the end of the 12-month follow-up period | 12 months following clinic intake |
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