Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

Schizophrenia Clinical Trial

Official title:

Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196286
• Other study ID #: 2010-BN-07
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: April 2017

Study information

• Verified date: May 2020
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder With Psychotic Features
• Disease
• Major Depression With Psychotic Features
• Mental Disorders
• Psychotic Disorder Not Otherwise Specified (NOS)
• Psychotic Disorders
• Recent-Onset Psychosis
• Schizoaffective Disorder
• Schizophrenia

Intervention

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
• Cognitive Remediation (CR)
Computer exercises designed to improve cognitive functioning (3hr/wk).

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Institute for Mental Health Research

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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/appi.ps.60.11.1477. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychotic Symptoms/Relapse Assessed Once Per Week		9 months
Secondary	Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization		9 months