Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis

NCT ID: NCT03970005

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-19

Study Completion Date

2026-09-30

Brief Summary

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The Ohio State University Early Psychosis Intervention Center is implementing a specialized clinical program to serve individuals who meet clinical high risk criteria for a psychosis. The purpose of this study is to evaluate the long-term outcomes among individuals participating in this clinical service.

Detailed Description

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The Ohio State University Early Psychosis Intervention Center (OSU EPICENTER) is implementing a specialized clinical program to serve individuals ages 12-25 who meet clinical high risk criteria for a psychosis (CHR-P). The purpose of this project is to evaluate (i) correlates of baseline characteristics among clinic participants; (ii) outcomes among individuals participating in this clinical service; and (iii) predictors and mediators of longitudinal outcomes among individuals participating in this clinical service.

Conditions

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Prodromal Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Step-Based Care Model

Care model comprised of psychosocial and pharmacological interventions in which individuals start with low-intensity interventions and progress onto progressively higher-intensity interventions until their reach remission criteria.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male and female patients between ages 12-25
* Individuals meeting clinical high-risk criteria for psychosis as determined using the Structured Interview for Psychosis Risk. Inclusive of individuals meeting any of the three CHR syndromes assessed by the SIPS (i.e., attenuated psychotic symptoms; brief intermittent psychosis, and genetic risk and functional deterioration) and/or individuals at all four current status specifiers for the SIPS (i.e., progression, persistence, partial remission, and full remission) given evidence that future worsening of symptoms and/or progression to psychosis is possible for individuals in each current status specifier category.
* Subjects with no evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4
* Fluent in English per self-report
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Breitborde

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicholas Breitborde, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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OSU Harding Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Breitborde NJK, Guirgis H, Stearns W, Carpenter KM, Lteif G, Pine JG, Storey N, Wastler H, Moe AM. The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study. BMJ Open. 2020 Jan 27;10(1):e034031. doi: 10.1136/bmjopen-2019-034031.

Reference Type DERIVED
PMID: 31992606 (View on PubMed)

Other Identifiers

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2018H0503

Identifier Type: -

Identifier Source: org_study_id

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