Overview

This trial is active, not recruiting.

Conditions recent-onset psychosis, schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depression with psychotic features, psychotic disorder not otherwise specified (nos)
Treatments multifamily group psychoeducation (mfg), cognitive remediation (cr)
Sponsor University of Arizona
Collaborator Institute for Mental Health Research
Start date June 2010
End date July 2016
Trial size 40 participants
Trial identifier NCT01196286, 2010-BN-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR)
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
cognitive remediation (cr)
Computer exercises designed to improve cognitive functioning (3hr/wk).
(Active Comparator)
Subjects provided with only multifamily group psychoeducation (MFG)
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

Primary Outcomes

Measure
Psychotic Symptoms/Relapse Assessed Once Per Week
time frame: 9 months

Secondary Outcomes

Measure
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
time frame: 9 months

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Principal investigator Nicholas Breitborde, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Arizona.