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Behavioral Intervention

Enhanced Coordinated Speciality Care (CSC 2.0) for Schizophrenia

N/A
Recruiting
Led By Dost Ongur, MD, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

"This trial aims to see if adding certain elements of care to the standard treatment for first-episode psychosis will increase the number of clinic visits. Participants will either receive the standard care or the standard care with

Who is the study for?
This trial is for individuals experiencing their first episode of psychosis, which could be related to conditions like schizophrenia or bipolar disorder. Participants must be receiving care at specific clinics in Massachusetts and are excluded if they don't attend these clinics.Check my eligibility
What is being tested?
The study compares standard coordinated specialty care (CSC) with an enhanced version (CSC 2.0), which adds individual peer support, digital outreach, extra care coordination, multi-family group therapy, and cognitive remediation to see if it increases clinic visits.See study design
What are the potential side effects?
Since the interventions involve additional support services rather than medications, traditional side effects are not a concern; however, participants may experience varying levels of comfort or emotional responses to the different types of therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Months Engaged in Care
Secondary outcome measures
Clinic Visit Number
Clinic Visit Type
Duration of Treatment
+1 more
Other outcome measures
Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)
Months Engaged in Care - extension of
Proportion of Early Detachment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Coordinated Speciality Care (CSC 2.0)Experimental Treatment5 Interventions
CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
Group II: Coordinated Specialty Care (CSC; standard of care)Active Control1 Intervention
Care as usual; no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Care Coordination
2016
N/A
~7000
Cognitive Remediation
2010
Completed Phase 3
~1790

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,935 Previous Clinical Trials
13,198,291 Total Patients Enrolled
45 Trials studying Schizophrenia
6,656 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,359 Total Patients Enrolled
249 Trials studying Schizophrenia
89,085 Patients Enrolled for Schizophrenia
Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,344 Total Patients Enrolled
19 Trials studying Schizophrenia
1,072 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"As per clinicaltrials.gov, this investigation is actively seeking eligible participants. The trial was initially listed on 2/1/2024 and last revised on 2/7/2024."

Answered by AI

Are multiple medical facilities within the United States involved in conducting this trial?

"Among the 6 sites offering participation in this study are Cambridge Health Alliance RISE Clinic in Cambridge, Massachusetts General Hospital FEPP Clinic in Boston, and Boston Medical Center WRAP located in Holyoke. Additionally, there are 3 more locations open for enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
Boston Medical Center WRAP
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Look further into this disease.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Enhanced Coordinated Specialty Care for Early Psychosis
Dost Ongur 2024. "Enhanced Coordinated Specialty Care for Early Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071858.
All > Bipolar Disorder
~233 spots leftby Oct 2028
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