Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

Study Overview
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Brief Summary
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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.

Official Title
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Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

Conditions
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Recent-Onset Psychosis, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)

Intervention / Treatment
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* Behavioral: Multifamily Group Psychoeducation (MFG)
* Behavioral: Cognitive Remediation (CR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFG and CR<br>Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR) | Behavioral: Multifamily Group Psychoeducation (MFG)<br>* 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<br>Behavioral: Cognitive Remediation (CR)<br>* Computer exercises designed to improve cognitive functioning (3hr/wk).<br>|
| Active Comparator: MFG<br>Subjects provided with only multifamily group psychoeducation (MFG) | Behavioral: Multifamily Group Psychoeducation (MFG)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic Symptoms/Relapse Assessed Once Per Week |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First-episode psychosis, cognitive remediation, family psychoeducation