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临床试验/NCT01570972
NCT01570972已完成不适用

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

University of Arizona1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Change from baseline in Social and vocational 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

  • •(Individual with Recent-Onset Psychosis):
  • •Diagnosis of a non-substance induced psychotic disorder (schizophrenia spectrum or affective spectrum) per the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR) criteria determined using the Structured Clinical Interview for the DSM-IV.
  • •Age between 18-35
  • •Willing to participate in interventions at University of Arizona Medical Center South Campus
  • •Willing to complete research assessments
  • •Duration of psychotic symptoms of less than 5 years determined using the Symptom Onset in Schizophrenia inventory
  • •Able to provide informed consent
  • •Fluent in English
  • •Willing to allow videotaping of group cognitive behavioral therapy sessions, multifamily group sessions, and family interaction task.
  • •Exclusion Criterion (Individual with Recent Onset Psychosis)
  • •No evidence of mental retardation as defined as never having qualified to receive services from the Arizona Department of Economic Security, Division of Developmental Disabilities.
  • •Inclusion Criteria (Family Caregiver):
  • •Must be someone that the individual with recent-onset psychosis identifies as providing support and care to the individual with recent-onset psychosis. Does not need to be a biological relative.
  • •Must spend considerable time with the individual with recent-onset psychosis as defined at 10 hours or more of direct contact per week.
  • •Willing to participate in participate in family intervention at University of Arizona Medical Center, South Campus for 2 years
  • •Willing to complete research assessments
  • •Able to provide informed consent
  • •Fluent in English
  • •Willing to allow videotaping of multifamily group sessions, Camberwell Family Interview, and family interaction task.
  • •Exclusion Criterion (Family Caregiver)
  • •Diagnosis of a psychotic disorder.

排除标准

  • 未提供

研究组 & 干预措施

MFG and GCBT

Other

There is a single arm for this study. All participants will be able to participate in MFG and GCBT

干预措施: Multifamily Group Psychoeducation (Behavioral)

MFG and GCBT

Other

There is a single arm for this study. All participants will be able to participate in MFG and GCBT

干预措施: Group Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

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

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 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

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 (1)

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