Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder With Psychotic Features; Major Depression With Psychotic Features; Psychotic Disorder Not Otherwise Specified (NOS)
MeSH terms: Depression; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Depressive Disorder, Major
Study type: Interventional

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.
    

Intervention name(s): Group Cognitive Behavioral Therapy; Multifamily Group Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): weekly; twice monthly
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; bipolar disorder with psychotic features; major depression with psychotic features; recent-onset psychosis; first-episode psychosis; cognitive behavioral therapy; multifamily group psychoeducation