Clinical trial NCT01570972: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from baseline in self-reported Physical Health at 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from baseline in Social and vocational Functioning at 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from baseline in Stage of Recovery at 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from baseline Service Utilization at 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from Baseline Quality of Life at 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Department of Psychiatry
state: Arizona
Study officials:
affiliation: The Ohio State Univerity
name: Nicholas Breitborde, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breitborde NJK, Bell EK, Woolverton C, Pine JG, Waslter H, Moe AM. Cost Utility of cognition-enhancing interventions for individuals with first-episode psychosis: a naturalistic evaluation. Cost Eff Resour Alloc. 2021 Jul 1;19(1):36. doi: 10.1186/s12962-021-00292-6.
citation: Breitborde NJ, Bell EK, Dawley D, Woolverton C, Ceaser A, Waters AC, Dawson SC, Bismark AW, Polsinelli AJ, Bartolomeo L, Simmons J, Bernstein B, Harrison-Monroe P. The Early Psychosis Intervention Center (EPICENTER): development and six-month outcomes of an American first-episode psychosis clinical service. BMC Psychiatry. 2015 Oct 28;15:266. doi: 10.1186/s12888-015-0650-3.