Back to resultsMultifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Primary Purpose
Recent-Onset Psychosis, Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifamily Group Psychoeducation (MFG)
Cognitive Remediation (CR)
Sponsored by
About this trial
This is an interventional treatment trial for Recent-Onset Psychosis focused on measuring First-episode psychosis, cognitive remediation, family psychoeducation
Eligibility 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
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MFG and CR
MFG
Arm Description
Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR)
Subjects provided with only multifamily group psychoeducation (MFG)
Outcomes
Primary Outcome Measures
Psychotic Symptoms/Relapse Assessed Once Per Week
Secondary Outcome Measures
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
Full Information
NCT ID
NCT01196286
First Posted
September 3, 2010
Last Updated
May 19, 2020
Sponsor
University of Arizona
Collaborators
Institute for Mental Health Research
1. Study Identification
Unique Protocol Identification Number
NCT01196286
Brief Title
Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Official Title
Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
Institute for Mental Health Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recent-Onset Psychosis, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)
Keywords
First-episode psychosis, cognitive remediation, family psychoeducation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MFG and CR
Arm Type
Experimental
Arm Description
Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR)
Arm Title
MFG
Arm Type
Active Comparator
Arm Description
Subjects provided with only multifamily group psychoeducation (MFG)
Intervention Type
Behavioral
Intervention Name(s)
Multifamily Group Psychoeducation (MFG)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation (CR)
Intervention Description
Computer exercises designed to improve cognitive functioning (3hr/wk).
Primary Outcome Measure Information:
Title
Psychotic Symptoms/Relapse Assessed Once Per Week
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Breitborde, Ph.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19880465
Citation
Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83. doi: 10.1176/ps.2009.60.11.1477.
Results Reference
background
PubMed Identifier
20536965
Citation
Rubinstein E, Breitborde NJ, Jenkins JH. Anthropological intervention early in psychosis. Early Interv Psychiatry. 2010 May;4(2):108-10. doi: 10.1111/j.1751-7893.2010.00175.x. No abstract available.
Results Reference
background
PubMed Identifier
20536970
Citation
Breitborde NJ, Srihari VH, Pollard JM, Addington DN, Woods SW. Mediators and moderators in early intervention research. Early Interv Psychiatry. 2010 May;4(2):143-52. doi: 10.1111/j.1751-7893.2010.00177.x.
Results Reference
background
PubMed Identifier
21226941
Citation
Breitborde NJ, Moreno FA, Mai-Dixon N, Peterson R, Durst L, Bernstein B, Byreddy S, McFarlane WR. Multifamily group psychoeducation and cognitive remediation for first-episode psychosis: a randomized controlled trial. BMC Psychiatry. 2011 Jan 12;11:9. doi: 10.1186/1471-244X-11-9.
Results Reference
derived
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Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
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