Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Schizophrenia Clinical Trial

Official title:

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570972
• Other study ID #: U. Az IRB 09-1113-02
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: April 2017

Study information

• Verified date: May 2020
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder With Psychotic Features
• Depression
• Depressive Disorder, Major
• Disease
• Major Depression With Psychotic Features
• Mental Disorders
• Psychotic Disorder Not Otherwise Specified (NOS)
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Group Cognitive Behavioral Therapy
weekly
• Multifamily Group Psychoeducation
twice monthly

Locations

Country	Name	City	State
United States	University of Arizona Department of Psychiatry	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months	General level of functioning to be assessed using the General Assessment of Functioning (GAF) scale	Baseline, 6 months, 12 months, 18 months, 24 months
Primary	Change from baseline in self-reported Physical Health at 6 months, 12 months, 18 months, and 24 months	Self-reported physical health assessed using the RAND-36 Health Survey	Baseline, 6 months, 12 months, 18 months, 24 months
Primary	Change from baseline in Social and vocational Functioning at 6 months, 12 months, 18 months, and 24 months	Social and Vocational functioning to be assessed using the Social Functioning Scale	Baseline, 6 months, 12 months, 18 months, 24 months
Primary	Change from baseline in Stage of Recovery at 6 months, 12 months, 18 months, and 24 months	Stage of recovery assessed using the Stage of Recovery Instrument	Baseline, 6 months, 12 months, 18 months, 24 months
Primary	Change from baseline Service Utilization at 6 months, 12 months, 18 months, and 24 months	Service utilization as assessed using the Service Utilization Record Form	Baseline, 6 months, 12 months, 18 months, 24 months
Primary	Change from Baseline Quality of Life at 6 months, 12 months, 18 months, and 24 months	Quality of Life as assessed using the WHO Quality of Life Scale Brief	Baseline, 6 months, 12 months, 18 months, 24 months