Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institute for Mental Health Research
Information provided by (Responsible Party):
Nicholas Breitborde, University of Arizona
ClinicalTrials.gov Identifier:
NCT01196286
First received: September 3, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Recent-Onset Psychosis
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder With Psychotic Features
Major Depression With Psychotic Features
Psychotic Disorder Not Otherwise Specified (NOS)
Behavioral: Multifamily Group Psychoeducation (MFG)
Behavioral: Cognitive Remediation (CR)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Psychotic Symptoms/Relapse Assessed Once Per Week [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196286

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85713
Sponsors and Collaborators
University of Arizona
Institute for Mental Health Research
Investigators
Principal Investigator: Nicholas Breitborde, Ph.D. University of Arizona
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicholas Breitborde, Assistant Professor, Department of Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT01196286     History of Changes
Other Study ID Numbers: 2010-BN-07
Study First Received: September 3, 2010
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
First-episode psychosis
cognitive remediation
family psychoeducation

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Schizophrenia
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 29, 2014