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

• Conditions: Prodromal Schizophrenia

• Registration Number: NCT03970005
• Lead Sponsor: Ohio State University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to remission of clinical-high risk status for psychosis	Remission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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 in scores on the MATRICS Consensus Cognitive Battery (MCCB) as compared to baseline assessment. The MCCB provides an overall cognitive composite score as well as subscale scores for processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem-solving, and social cognition. Scores range from 0-100 with higher scores indicative of greater cognitive functioning
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 in scores on the Columbia Suicide Severity Rating Scale (C-SSRS)as compared to baseline assessment. The C-SSRS provide two subscales: suicidal ideation and suicidal behavior. The former is an ordinal rating scale ranging from 0-6 with higher scores indicative of greater suicidal ideation. The latter is a nominal scale identifying the absence/presence of different suicidal behaviors.
Change from baseline in symptomatology 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 scores on the Structured Interview for Psychosis Risk Syndromes as compared to baseline assessment. Item scores range from 0-6 with higher scores indicative of worse symptomatology
Change from baseline in service utilization 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 utilization of health care and related social services as tracked using the Service Utilization and Resources Form as compared to baseline assessment.
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	Change in scores on the Hamilton Anxiety Scale scale as compared to baseline assessment.. The total score on this measure ranges from 0-56 with higher scores indicative of worse anxiety
Change from baseline in social 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 in scores on the Global Functioning: Social as compared to baseline assessment. Scores range from 1-10 with higher scores indicative of better social functioning
Change from baseline in health-related 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 health-related quality of life as assessed using the RAND 36-Item Health Survey as compared to baseline assessment. Scores on this measure range from 0-100 with higher scores indicative of greater health-related quality of life.
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 scores on WHO Quality of Life Scale Brief (WHOQOL-BREF) as compared to baseline assessment; The WHOQOL-BREF provides scores for four subscales of quality of life: physical health, psychological health, social relationships, and environment. Scores range from 0-100 with higher scores indicative of greater quality of life
Change from baseline in depressed mood 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 scores on the Calgary Depression Scale for Schizophrenia as compared to baseline assessment. Total scores range from 0-3 with higher scores indicative of worse depression
Change from baseline in role 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 in scores on the Global Functioning: Role as compared to baseline assessment. Scores range from 1-10 with higher scores indicative of better role functioning
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 in scores on the HABITS scale as compare to baseline as compared to baseline assessment. The HABITS assesses the frequency/amount of use of different illicit substances with higher scores indicative of greater frequency/amount. There is no predetermined possible range of scores as scores are raw values with regard to frequency/amount of use (e.g., number of cigarettes smoked per day)
Change from baseline in medication adherence 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 medication adherence as tracked using the Medication Adherence rating Scale as compared to baseline assessment. Scores range from 0-10 with higher scores indicative of greater adherence to prescribed medication.
Change from baseline in experience of trauma 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 experience of trauma as tracked using the Brief Trauma Questionnaire as compared to baseline assessment.

Trial Locations

Locations (1)

OSU Harding Hospital; 🇺🇸 Columbus, Ohio, United States