Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis



Status:Completed
Conditions:Depression, Schizophrenia, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 35
Updated:4/26/2017
Start Date:February 2010
End Date:April 2017

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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.

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.

Inclusion Criteria (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.
We found this trial at
1
site
Tucson, Arizona 85724
Principal Investigator: Nicholas Breitborde, Ph.D.
Phone: 520-874-7531
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Tucson, AZ
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