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Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004364
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Northwell Health

Study Description
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Brief Summary:
The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

Condition or disease Intervention/treatment
First Episode Psychosis Other: Coordinated Specialty Care (CSC)

Detailed Description:

The RAISE ETP study, designed and conducted by our group, signaled that a Coordinated Specialty Care (CSC) model could be feasibly delivered in community mental health clinics in multiple states and was effective. Since then, with the support of SAMSHA block grants to states, there are CSC programs across the nation.

The goal of this project is to develop a learning health system with sites providing CSC treatment of first-episode psychosis (FEP). Sites are drawn from five states: Connecticut, Florida, Michigan, Oklahoma and South Carolina. They vary in populations served, levels of funding available and research experience. All are committed to advancing the development of CSC using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.

Study Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : July 27, 2024
Estimated Study Completion Date : July 27, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Coordinated Specialty Care (CSC)
    CSC is an integrated and team-based treatment model for first episode psychosis elements include psychotherapy, supported employment and education, family education and support, and pharmacotherapy.

Outcome Measures
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Primary Outcome Measures :
  1. Number of Enrolled participants [ Time Frame: 5 years of the project ]
    Number of enrolled participants into the learning health system


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
15 to 40 year olds with first episode psychosis enrolled in network CSC program
Criteria

Inclusion Criteria:

  • Enrolled in CSC program

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004364


Contacts
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Contact: Patricia Marcy, BSN 347-439-8035 pmarcy@northwell.edu
Contact: Cristina Gonzalez, MS 347-804-3605

Locations
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United States, Florida
Henderson Behavioral Health Recruiting
Lauderdale Lakes, Florida, United States, 33319
Contact: Suzelle Guinart         
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04004364    
Other Study ID Numbers: 19-0307
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders