Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to remission of clinical-high risk status for psychosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Time to remission of clinical-high risk status for psychosis
时间窗: 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.
次要结局
- 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 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 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 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 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 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 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 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 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 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 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 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)
研究者
Nicholas Breitborde
Associate Professor
Ohio State University