Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis

NCT01570972 | Completed

• 1 other identifier: U. Az IRB 09-1113-02
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

MFG and GCBT

OTHER

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

Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Multifamily Group Psychoeducation

Interventions

Group Cognitive Behavioral Therapy BEHAVIORAL

weekly

MFG and GCBT

Multifamily Group Psychoeducation BEHAVIORAL

twice monthly

MFG and GCBT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Department of Psychiatry

Tucson, Arizona, 85724, United States

Location

Related Publications (3)

• Moe AM, Wastler HM, Pine JG, Breitborde NJK. Metacognitive Skills Training and Computerized Cognitive Remediation among Individuals with First-Episode Psychosis: Influence on Social Cognition. Psychosis. 2023;15(4):418-423. doi: 10.1080/17522439.2022.2111595. Epub 2023 Jan 4.

  PMID: 38053744 DERIVED

• 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.

  PMID: 34210341 DERIVED

• 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.

  PMID: 26511605 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Nicholas Breitborde, Ph.D.

  The Ohio State Univerity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: April 4, 2012
• Study Start: February 1, 2010
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

US (1)