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Clinical Trials/NCT01570972
NCT01570972
Completed
N/A

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

University of Arizona1 site in 1 country103 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Arizona
Enrollment
103
Locations
1
Primary Endpoint
Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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 All participants will be provided with 2 years of of GCBT and MFG and will complete regular assessments with regard to clinical and functional outcomes as well as potential mediators and moderators of these outcomes. Significance of the Study 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 lead to improvements in the treatment of first-episode psychosis.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
April 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicholas Breitborde

Assistant Professor, Department of Psychiatry

University of Arizona

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months

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

Study Sites (1)

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