Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 21, 2020
May 1, 2020
6.8 years
September 3, 2010
May 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychotic Symptoms/Relapse Assessed Once Per Week
9 months
Secondary Outcomes (1)
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
9 months
Study Arms (2)
MFG and CR
EXPERIMENTALSubjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR)
MFG
ACTIVE COMPARATORSubjects provided with only multifamily group psychoeducation (MFG)
Interventions
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
Computer exercises designed to improve cognitive functioning (3hr/wk).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- Institute for Mental Health Researchcollaborator
Study Sites (1)
University of Arizona
Tucson, Arizona, 85713, United States
Related Publications (4)
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.
PMID: 19880465BACKGROUNDRubinstein 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.
PMID: 20536965BACKGROUNDBreitborde 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.
PMID: 20536970BACKGROUNDBreitborde 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.
PMID: 21226941DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Breitborde, Ph.D.
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Psychiatry
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 8, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
May 21, 2020
Record last verified: 2020-05