Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Not Applicable

Completed

• Conditions: Schizophrenia; Major Depression With Psychotic Features; Psychotic Disorder Not Otherwise Specified (NOS); Bipolar Disorder With Psychotic Features; Schizoaffective Disorder
• Interventions: Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Multifamily Group Psychoeducation

• Registration Number: NCT01570972
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MFG and GCBT	Multifamily Group Psychoeducation	There is a single arm for this study. All participants will be able to participate in MFG and GCBT
MFG and GCBT	Group Cognitive Behavioral Therapy	There is a single arm for this study. All participants will be able to participate in MFG and GCBT

Primary Outcome Measures

Name	Time	Method
Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months	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	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	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	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	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	Baseline, 6 months, 12 months, 18 months, 24 months	Quality of Life as assessed using the WHO Quality of Life Scale Brief

Trial Locations

Locations (1)

University of Arizona Department of Psychiatry; 🇺🇸 Tucson, Arizona, United States