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Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group Cognitive Behavioral Therapy

Multifamily Group Psychoeducation

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring 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

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Arizona Department of Psychiatry

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MFG and GCBT

Arm Description

There is a single arm for this study. All participants will be able to participate in MFG and GCBT

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01570972

First Posted

November 7, 2011

Last Updated

May 19, 2020

Sponsor

University of Arizona

1. Study Identification

Unique Protocol Identification Number

NCT01570972

Brief Title

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Official Title

Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

February 2010 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MFG and GCBT

Arm Type

Other

Arm Description

There is a single arm for this study. All participants will be able to participate in MFG and GCBT

Intervention Type

Behavioral

Intervention Name(s)

Group Cognitive Behavioral Therapy

Intervention Description

weekly

Intervention Type

Behavioral

Intervention Name(s)

Multifamily Group Psychoeducation

Intervention Description

twice monthly

Primary Outcome Measure Information:

Title

Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months

Description

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

Time Frame