Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
This study is currently recruiting participants.
Verified March 2013 by University of Arizona
Sponsor:
University of Arizona
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: March 27, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Bipolar Disorder
Depression
Mental Disorders
Psychotic Disorders
Schizophrenia
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196286
Contacts
| Contact: Nicholas Breitborde, Ph.D. | (520) 874-7531 | breitbor@email.arizona.edu |
Locations
| United States, Arizona | |
| University of Arizona | Recruiting |
| Tucson, Arizona, United States, 85713 | |
| Principal Investigator: Nicholas Breitborde, Ph.D. | |
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: | March 27, 2013 |
| 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 May 16, 2013