Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

This study is currently recruiting participants.
Verified February 2014 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Nicholas Breitborde, University of Arizona
ClinicalTrials.gov Identifier:
NCT01570972
First received: November 7, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder With Psychotic Features
Major Depression With Psychotic Features
Psychotic Disorder Not Otherwise Specified (NOS)
Behavioral: Group Cognitive Behavioral Therapy
Behavioral: Multifamily Group Psychoeducation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of Life as assessed using the WHO Quality of Life Scale Brief


Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MFG and GCBT
There is a single arm for this study. All participants will be able to participate in MFG and GCBT
Behavioral: Group Cognitive Behavioral Therapy
weekly
Behavioral: Multifamily Group Psychoeducation
twice monthly

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570972

Contacts
Contact: Nicholas Breitborde, Ph.D. (520) 874-7531

Locations
United States, Arizona
University of Arizona Department of Psychiatry Recruiting
Tucson, Arizona, United States, 85724
Contact: Nicholas Breitborde, Ph.D.    520-874-7531      
Principal Investigator: Nicholas Breitborde, Ph.D.         
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Nicholas Breitborde, Ph.D. University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Nicholas Breitborde, Assistant Professor, Department of Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT01570972     History of Changes
Other Study ID Numbers: U. Az IRB 09-1113-02
Study First Received: November 7, 2011
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
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

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Schizophrenia and Disorders with Psychotic Features
Bipolar Disorder
Depression
Depressive Disorder
Schizophrenia
Depressive Disorder, Major
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014