NCT01570972

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Bipolar Disorder With Psychotic Features
• Major Depression With Psychotic Features
• Psychotic Disorder Not Otherwise Specified (NOS)

Interventions

Type	Name	Description
BEHAVIORAL	Group Cognitive Behavioral Therapy	weekly
BEHAVIORAL	Multifamily Group Psychoeducation	twice monthly

Timeline

• Start date: 2010-02-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2012-04-04
• Last updated: 2020-05-21

Locations

1 site across 1 country: United States