NCT00481156

Brief Summary

The purpose of this study is to examine behavioral and functional brain changes occuring as a result of cognitive remediation training in patients with schizophrenia. Extension and specificity of related changes will also be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

May 30, 2007

Last Update Submit

May 1, 2018

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • Working Memory performance

    N-Back Performance

    Post-test

  • Brain activation

    Changes in prefrontal cortical functioning

    Post-test

Study Arms (3)

Patients: Cognitive Remediation

EXPERIMENTAL

Patients in the cognitive REM condition attended up to 25 h of training in small groups over 4-6 weeks based on the approach to cognitive remediation described by Wexler and Bell (2005). Patients performed tasks designed to train attention and memory from the battery available within a computerized software package (CogPack Marker Software). This training protocol has been shown to improve memory and executive functioning in patients with schizophrenia (Sartory et al, 2005) and tasks chosen were designed to produce improved working memory and attention capacity in the treated group. In addition, patients in the REM group trained on the word N-back one to two times a week and on N-back tasks using a variety of other stimuli (such as faces) one to two times a week to support the generalization of working memory improvements.

Behavioral: Cognitive Remediation

Patients: Cognitive-Behavioral Social Skills Training

ACTIVE COMPARATOR

Patients in the CBSST group also attended up to 25 h of treatment but followed a manualized group therapy protocol (Granholm et al, 2005) using cognitive and behavioral therapy methods to increase patients' skills in symptom recognition, communication, problem solving, and relapse prevention. In both conditions, the facilitators interacted with the clients throughout small group (B4 patients) sessions: in the REM group, this mostly involved brief one-on-one discussions regarding task performance; in the CBSST condition, this interaction was in the context of the group milieu.

Behavioral: Cognitive Behavioral Social Skills Training

Controls: Retest control group

OTHER

Estimate of normal brain functioning and retest effects

Other: Retest in Health Controls

Interventions

Cognitive RemediationBEHAVIORAL
Patients: Cognitive Remediation
Cognitive Behavioral Social Skills TrainingBEHAVIORAL
Patients: Cognitive-Behavioral Social Skills Training
Retest in Health ControlsOTHER

Pre/Post test performance and neuroimaging only

Controls: Retest control group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Stable outpatient

You may not qualify if:

  • Current drug abuse or dependence
  • History of neurological damage, disorder, or disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Haut KM, Lim KO, MacDonald A 3rd. Prefrontal cortical changes following cognitive training in patients with chronic schizophrenia: effects of practice, generalization, and specificity. Neuropsychopharmacology. 2010 Aug;35(9):1850-9. doi: 10.1038/npp.2010.52. Epub 2010 Apr 28.

    PMID: 20428109RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Angus W MacDonald, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Kelvin O Lim, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were randomized to computer-based cognitive training or active social-skills groups. Healthy controls (n=9) received no treatment.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

March 1, 2005

Primary Completion

February 28, 2007

Study Completion

February 28, 2007

Last Updated

May 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)