Skip to main content
OpenTrials
Completed

NCT Number: NCT01570972

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Department of Psychiatry

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Cognitive Behavioral Therapy

Behavioral

weekly

Multifamily Group Psychoeducation

Behavioral

twice monthly

Primary outcomes

  1. 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

    General level of functioning to be assessed using the General Assessment of Functioning (GAF) scale

  2. 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

    Self-reported physical health assessed using the RAND-36 Health Survey

  3. 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

    Social and Vocational functioning to be assessed using the Social Functioning Scale

  4. 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

    Stage of recovery assessed using the Stage of Recovery Instrument

  5. 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

    Service utilization as assessed using the Service Utilization Record Form

  6. 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

    Quality of Life as assessed using the WHO Quality of Life Scale Brief

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2012
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.