NCT01196286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

6.8 years

First QC Date

September 3, 2010

Last Update Submit

May 19, 2020

Conditions

Keywords

First-episode psychosiscognitive remediationfamily psychoeducation

Outcome Measures

Primary Outcomes (1)

  • Psychotic Symptoms/Relapse Assessed Once Per Week

    9 months

Secondary Outcomes (1)

  • Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization

    9 months

Study Arms (2)

MFG and CR

EXPERIMENTAL

Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR)

Behavioral: Multifamily Group Psychoeducation (MFG)Behavioral: Cognitive Remediation (CR)

MFG

ACTIVE COMPARATOR

Subjects provided with only multifamily group psychoeducation (MFG)

Behavioral: Multifamily Group Psychoeducation (MFG)

Interventions

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

MFGMFG and CR

Computer exercises designed to improve cognitive functioning (3hr/wk).

MFG and CR

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85713, United States

Location

Related Publications (4)

  • 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.

    PMID: 19880465BACKGROUND
  • 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.

    PMID: 20536965BACKGROUND
  • 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.

    PMID: 20536970BACKGROUND
  • 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.

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nicholas Breitborde, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 8, 2010

Study Start

June 1, 2010

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations