Clinical trial NCT01196286: Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Official title: Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Institute for Mental Health Research
First posted: 2010-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Psychotic Symptoms/Relapse Assessed Once Per Week
timeFrame: 9 months
Secondary outcomes:
measure: Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
timeFrame: 9 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: Ohio State University
name: Nicholas Breitborde, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.