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临床试验/NCT03369730
NCT03369730已完成不适用

Early Stage Identification and Engagement to Reduce Duration of Untreated Psychosis (EaSIE)

Icahn School of Medicine at Mount Sinai3 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2018年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
3
主要终点
Duration of Untreated Psychosis (DUP)

研究概览

简要总结

The goal of this project is to investigate whether a systematic screening approach for individuals with first episode psychosis (FEP) can substantially reduce Duration of Untreated Psychosis (DUP). The study team will evaluate the feasibility of screening a consecutive help-seeking population entering mental health services in order to facilitate early identification of FEP cases, rapid referral to specialty care and engagement in treatment.

详细描述

Psychosis typically emerges in late adolescence or early adulthood, during a vital stage in social and cognitive development, which can have a profoundly adverse impact on an individual's long-term functioning. Numerous studies find a substantial delay between the onset of psychosis and the initiation of specialty treatment for first episode psychosis (FEP), with the duration of untreated psychosis (DUP) typically over one year in the U.S. Better detection strategies are needed to improve identification of individuals with FEP and to rapidly engage them in Coordinated Specialty Care (CSC) aimed at restoring functioning. The onset of psychosis is preceded by a prodromal phase characterized by attenuated psychotic symptoms and decline in functioning. This phase (at-risk mental state: ARMS) is a potential target for strategies aimed at improving outcome by reducing DUP through regular symptom monitoring. This study will investigate whether a U.S. adaptation of a successful detection approach from the Netherlands can reduce DUP in the U.S. setting. The Dutch study found that screening of a consecutive help-seeking population entering mental health services captures significantly more FEP and ARMS cases than clinician referrals from mental health centers. Therefore screening may be an effective strategy for identifying individuals with psychotic symptoms earlier on in the course of their illness. This study will implement and evaluate a systematic screening for psychotic symptoms in community mental health clinics in order to facilitate rapid identification and engagement in treatment of individuals with FEP. Individuals ages 12 to 30 entering child/adolescent and adult community mental health clinics (CMHCs) within Mount Sinai Health System will be screened with the Prodromal Questionnaire - Brief Version (PQ-B). Those who screen positive will be assessed by the Structured Interview for Prodromal Syndromes (SIPS) and referred to stage-specific specialty care. Individuals with FEP will be referred to CSC programs: OnTrackNY and PEER. Individuals with ARMS will be monitored and referred to ICanFeelBetter program for ARMS. DUP will be measured for all individuals who meet SIPS psychosis criteria. The study team hypothesizes that screening for psychotic symptoms in CMHCs will be feasible and acceptable, and that the average DUP of FEP individuals identified with screening will be less than 3 months, the maximum time between onset of psychotic symptoms and engagement in CSC recommended by the World Health Organization. In order to optimize screening and treatment engagement strategies for reducing DUP, the clinical team will identify facilitators and barriers to FEP care through in-depth qualitative interviews with patients and caregivers, and by mapping pathways to FEP care. The study team will also conduct in-depth qualitative interviews with clinicians to explore their experience with the screening and referral process.

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 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 12- 30
  • ability to participate in assessments in English
  • ability to provide informed consent (assent for those under age 18)
  • meet criteria for psychosis or psychosis risk on SIPS

排除标准

  • previous diagnosis of schizophrenia or schizoaffective disorder.

结局指标

主要结局

Duration of Untreated Psychosis (DUP)

时间窗: Day 1

The DUP is defined as the time, in weeks, between onset of psychotic symptoms and initiation of FEP treatment, in the case of this study, entry into Coordinated Specialty Care (CSC) programs for first episode psychosis (FEP).

次要结局

  • Rate of CHR cases(Day 1)
  • Rate of completed PQ-B screen.(Day 1)
  • Rate of completed SIPS(Day 1)
  • Rates of FEP cases(Day 1)
  • Rate of ARMS cases(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yulia Landa

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (3)

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