Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01196286
• Date of registration: 03/09/2010
• Primary sponsor: University of Arizona
• Public title: Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
• Scientific title: Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
• Date of first enrolment: June 2010
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01196286
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Nicholas Breitborde, Ph.D.

• Name: Nicholas Breitborde, Ph.D.
• Affiliation: University of Arizona

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bipolar Disorder With Psychotic Features

Major Depression With Psychotic Features

Psychotic Disorder Not Otherwise Specified (NOS)

Recent-Onset Psychosis

Schizoaffective Disorder

Schizophrenia

Intervention(s)

Behavioral: Cognitive Remediation (CR)

Behavioral: Multifamily Group Psychoeducation (MFG)

Primary Outcome(s)

Psychotic Symptoms/Relapse Assessed Once Per Week [Time Frame: 9 months]

Secondary Outcome(s)

Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization [Time Frame: 9 months]

Secondary ID(s)

2010-BN-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institute for Mental Health Research