Enrolling by invitation NCT03970005
Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Step-Based Care Model.
- Who it may be relevant to
- Registry conditions: Prodromal Schizophrenia. Basic parameters: 12 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Time to remission of clinical-high risk status for psychosis [Time frame: Remission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks]
Secondary outcome measures (12)
- Change from baseline in quality of life assessed every six months for up to 24 months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in depressed mood assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in symptomatology assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in social functioning assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in role functioning assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in service utilization assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in medication adherence assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
- Change from baseline in experience of trauma assessed every six months for up to 24 months [Time frame: Assessed at baseline and every six months throughout the completion of the study for up to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- OSU Harding Hospital — Columbus
Publications
- 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
Identifiers
NCT: NCT03970005 · 2018H0503