Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis
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
- 否
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
Nicholas Breitborde
Assistant Professor, Department of Psychiatry
University of Arizona
