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

Study Overview
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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.

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

Conditions
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Prodromal Schizophrenia

Intervention / Treatment
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* Behavioral: Step-Based Care Model


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in quality of life assessed every six months 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 | 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 | 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 | 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 | 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. | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Change in utilization of health care and related social services as tracked using the Service Utilization and Resources Form as compared to baseline assessment. | 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 | 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. | 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 | Change in experience of trauma as tracked using the Brief Trauma Questionnaire as compared to baseline assessment. | Assessed at baseline and every six months throughout the completion of the study for up to 24 months | 
| Change from baseline in health-related quality of life assessed every six months 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. | Assessed at baseline and every six months throughout the completion of the study for up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosis, treatment, clinical high-risk