跳至主要内容
临床试验/NCT01570972
NCT01570972已完成不适用

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

University of Arizona2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months

研究概览

简要总结

Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are evidence-based treatments for first episode psychosis. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could improve the clinical benefits facilitated by these two interventions.

详细描述

Background

There is growing evidence that the majority of the psychosocial deterioration that accompanies psychotic disorders occurs during the first few years of illness and that the prevention or delay of early deterioration may be associated with a better course of illness. Two interventions which have been shown to improve the course of recent-onset psychosis are multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT]. Both family psychoeducation and cognitive behavioral therapy have been recommended as components of usual care for psychotic disorders by the Schizophrenia Patient Oriented Research Team convened by the U.S. Department of Health and Human Services (10) as well as other international health organizations. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could improve the clinical benefits facilitated by these two interventions.

Purpose and Objectives

The goal of this study is to clarify the mechanisms through which MFG and GCBT produce their clinical benefits (i.e., mediators) and identify the factors that may maximize an individual's response to these two empirically-validated interventions (i.e., moderators).

Methods

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

General level of functioning to be assessed using the General Assessment of Functioning (GAF) scale

Change from baseline in self-reported Physical Health at 6 months, 12 months, 18 months, and 24 months

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Self-reported physical health assessed using the RAND-36 Health Survey

Change from baseline in Social and vocational Functioning at 6 months, 12 months, 18 months, and 24 months

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Social and Vocational functioning to be assessed using the Social Functioning Scale

Change from baseline in Stage of Recovery at 6 months, 12 months, 18 months, and 24 months

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Stage of recovery assessed using the Stage of Recovery Instrument

Change from baseline Service Utilization at 6 months, 12 months, 18 months, and 24 months

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Service utilization as assessed using the Service Utilization Record Form

Change from Baseline Quality of Life at 6 months, 12 months, 18 months, and 24 months

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Quality of Life as assessed using the WHO Quality of Life Scale Brief

次要结局

未报告次要终点

研究者

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

Nicholas Breitborde

Assistant Professor, Department of Psychiatry

University of Arizona

研究点 (2)

Loading locations...

相似试验