NCT00063336

Brief Summary

This study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2001

Typical duration for not_applicable schizophrenia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

November 8, 2013

Status Verified

May 1, 2009

Enrollment Period

3.9 years

First QC Date

June 25, 2003

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

  • Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities

    Measured pre- and post-treatment

  • Schizophrenia symptoms

    Measured pre- and post-treament

  • UCSD Performance-Based Skills Assessment

    Measured pre- and post-treatment

Study Arms (2)

1

EXPERIMENTAL

Participants will receive cognitive remediation treatment.

Behavioral: Cognitive Remediation

2

EXPERIMENTAL

Participants will receive computer-skills training.

Behavioral: Computer-skills training

Interventions

Cognitive RemediationBEHAVIORAL

A computerized cognitive rehabilitation treatment with day-program activities

1
Computer-skills trainingBEHAVIORAL

A computerized cognitive rehabilitation treatment with day-program activities

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV criteria for schizophrenia or schizoaffective disorder
  • In need of intensive outpatient care
  • Treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry

You may not qualify if:

  • Auditory or visual impairment
  • Mental retardation (IQ less than 70)
  • Traumatic brain injury with loss of consciousness
  • Presence or history of any neurological illness that may affect brain physiology
  • Lack of proficiency in English
  • Concurrent substance abuse and/or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schizophrenia Rehabilitation Program, Institutes of Living

Hartford, Connecticut, 06106, United States

Location

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

  • Matthew M. Kurtz, PhD

    Schizophrenia Rehabilitation Program, Institutes of Living

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2003

First Posted

June 27, 2003

Study Start

December 1, 2001

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

November 8, 2013

Record last verified: 2009-05

Locations

US(1)