跳至主要内容
临床试验/NCT01597141
NCT01597141已完成不适用

Psychosis: Early Detection, Intervention and Prevention

MaineHealth2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
MaineHealth
入组人数
100
试验地点
2
主要终点
Onset of Psychosis

研究概览

简要总结

The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.

详细描述

The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.

The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Prodromal psychotic symptoms
  • Age 12-35
  • In catchment area (greater Portland, Maine)

排除标准

  • Previous or current psychotic episode
  • IQ less than 70
  • Outside catchment area
  • Toxic psychosis

结局指标

主要结局

Onset of Psychosis

时间窗: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months

Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.

次要结局

  • Functioning(24 months)

研究者

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

William McFarlane

Principal Investigator

MaineHealth

研究点 (2)

Loading locations...

相似试验