Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

NCT01196286

Recent-Onset Psychosis Schizophrenia Schizoaffective Disorder +3 more

COMPLETED NA

Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions

NCT00358709

Schizophrenia

COMPLETED PHASE3

Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy

NCT00791440

Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

COMPLETED NA

Improving Negative Symptoms of Psychosis In Real-world Environments

NCT02170051

Schizophrenia

COMPLETED NA

Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial

NCT07146802

Schizophrenia Spectrum Disorder

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MFG and GCBT

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

Group Type OTHER

Group Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

weekly

Multifamily Group Psychoeducation

Intervention Type BEHAVIORAL

twice monthly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group Cognitive Behavioral Therapy

weekly

Intervention Type BEHAVIORAL

Multifamily Group Psychoeducation

twice monthly

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No