Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

May 19, 2020 updated by: Nicholas Breitborde, University of Arizona
The goal of this study is to determine whether pairing multifamily group psychoeducation with cognitive remediation may facilitate improved outcomes among individuals with recent-onset psychosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85713
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Individual with Recent-Onset Psychosis):

  • Diagnosis of a non-substance induced psychotic disorder per 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
  • Must have a family caregiver who is willing to participate in the study
  • Willing to allow videotaping of multifamily group therapy sessions.
  • 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.

Exclusion Criteria (Individual with Recent-Onset Psychosis):

  • Failure to meet inclusion criteria

Inclusion Criteria (Caregiving Relative of Individual with Recent-Onset Psychosis):

  • 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.

Exclusion Criteria (Caregiving Relative of Individual with Recent-Onset Psychosis):

  • Failure to meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MFG and CR
Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR)
Behavioral: Multifamily Group Psychoeducation (MFG)
Participation in multifamily psychoeducation comprised of (i) three individual sessions with family and individual with psychosis, (ii) one psychoeducational workshop, and (iiI) twice monthly multifamily meetings to complete structured problem-solving activity
Behavioral: Cognitive Remediation (CR)
Computer exercises designed to improve cognitive functioning (3hr/wk).
ACTIVE_COMPARATOR: MFG
Subjects provided with only multifamily group psychoeducation (MFG)
Behavioral: Multifamily Group Psychoeducation (MFG)
Participation in multifamily psychoeducation comprised of (i) three individual sessions with family and individual with psychosis, (ii) one psychoeducational workshop, and (iiI) twice monthly multifamily meetings to complete structured problem-solving activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychotic Symptoms/Relapse Assessed Once Per Week
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Institute for Mental Health Research

Investigators

  • Principal Investigator: Nicholas Breitborde, Ph.D., Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (ESTIMATE)

September 8, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-BN-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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