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

NCT03970005 | Enrolling By Invitation

• 1 other identifier: 2018H0503
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prodromal Schizophrenia

Keywords

psychosis; treatment; clinical high-risk

Outcome Measures

Primary Outcomes (1)

• Time to remission of clinical-high risk status for psychosis

  Using criteria inspired by Nelson et al. (2018), remission of clinical high risk status for psychosis is defined as simultaneous remission of both (i) symptoms and (ii) functional deficits associated with prodromal psychosis. Remission of symptoms is defined as all positive symptom items scored less than 3 on the Structured Clinical Interview for Prodromal States (SIPS). Each item is rated from 0-6 with higher scores indicating greater severity of symptoms. Remission of functional deficits is defined as a 5-point increase on the Personal and Social Performance scale (PSP: Morosini et al., 2000) as compared to baseline assessment or the PSP score ≥ 70. Scores range from 0-100 with higher scores indicative of better personal and social functioning.

  Remission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks

Secondary Outcomes (13)

• Change from baseline in quality of life assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

• Change in from baseline in cognitive functioning assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

• Change from baseline in suicidality assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

• Change from baseline in substance use severity assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

• Change from baseline in anxiety assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

Other Outcomes (28)

• Change from baseline in capability for suicide/lethal self-injury assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

• Change from baseline in beliefs about use of alcohol assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

• Change from baseline in beliefs about use of marijuana assessed every six months for up to 24 months

  Assessed at baseline and every six months throughout the completion of the study for up to 24 months

Interventions

Step-Based Care Model BEHAVIORAL

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.

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This program evaluation will include all patients referred to The OSU EPICENTER CHR-P clinical program.

You may qualify if:

• 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

Sponsors & Collaborators

• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator
• Ohio State University: lead

Study Sites (1)

OSU Harding Hospital

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 31992606 DERIVED

MeSH Terms

Conditions

Schizotypal Personality Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Nicholas Breitborde, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 31, 2019
• Study Start: April 19, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)