NCT00930150

Brief Summary

This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

June 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 19, 2011

Status Verified

November 1, 2010

Enrollment Period

7 months

First QC Date

June 26, 2009

Last Update Submit

April 15, 2011

Conditions

Schizophrenia

Keywords

Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a multisite trial using cognitive remediation

    Measured at post-treatment

Secondary Outcomes (1)

  • Effect of cognitive remediation on functional outcomes, including change from baseline on UCSD Performance Based Skills Assessment (UPSA) total score, Specific Levels of Functioning (SLOF) total score, and Cognitive Assessment Interview (CAI) total score

    Measured at post-treatment

Study Arms (2)

Posit Science Intervention

EXPERIMENTAL

Participants will receive targeted cognitive training and participate in a bridging group.

Behavioral: Targeted cognitive trainingBehavioral: Bridging groups

Control

ACTIVE COMPARATOR

Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.

Behavioral: Computer controlBehavioral: Health and wellness groups

Interventions

Targeted cognitive trainingBEHAVIORAL

Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves

Posit Science Intervention
Computer controlBEHAVIORAL

Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content

Control
Bridging groupsBEHAVIORAL

Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization

Posit Science Intervention
Health and wellness groupsBEHAVIORAL

Weekly group meetings that teach participants health and wellness skills

Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Demonstrates adequate decisional capacity to make a choice about participating in the research study
  • Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
  • Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5)
  • Meets all of the following cognitive performance and English language criteria:
  • Learned English before age 12
  • Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator
  • Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ
  • Able to state specific goals relevant to the intervention that participant would like to achieve
  • Able to participate in the computerized intervention, based on the judgment of the investigator

You may not qualify if:

  • Psychiatric hospitalization within 8 weeks of random assignment
  • Adjustment to antipsychotic treatment within 4 weeks of random assignment
  • Currently taking an anticholinergic medication
  • DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
  • History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Yale University/Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

University of Minnesota School of Medicine

Minneapolis, Minnesota, 55454, United States

Location

The University of North Carolina

Chapel Hill, North Carolina, 27599-7160, United States

Location

Philadelphia VA Medical Center-116A

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

  • Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

    PMID: 33539561DERIVED

  • Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

    PMID: 28433500DERIVED

  • Keefe RS, Vinogradov S, Medalia A, Buckley PF, Caroff SN, D'Souza DC, Harvey PD, Graham KA, Hamer RM, Marder SM, Miller DD, Olson SJ, Patel JK, Velligan D, Walker TM, Haim AJ, Stroup TS. Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. J Clin Psychiatry. 2012 Jul;73(7):1016-22. doi: 10.4088/JCP.11m07100. Epub 2012 May 15.

    PMID: 22687548DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Health

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Richard Keefe, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • T. Scott Stroup, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 30, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 19, 2011

Record last verified: 2010-11

Locations

US(9)