NCT00430560

Brief Summary

This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:

  1. 1.does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?
  2. 2.Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?
  3. 3.Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?
  4. 4.What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_2 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

January 31, 2007

Last Update Submit

September 7, 2017

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

work therapycognitive rehabilitationschizophreniaschizoaffective disordertreatment outcome

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological test performance

    data collection completed

Secondary Outcomes (4)

  • Hours of productive activity

    data collection completed

  • Hours worked

    data collection completed

  • Quality of life

    data collection completed

  • Psychiatric symptoms

    data collection completed

Study Arms (2)

1

ACTIVE COMPARATOR

work therapy

Procedure: work therapyBehavioral: work therapy

2

EXPERIMENTAL

work therapy plus cognitive remediation

Behavioral: cognitive rehabilitation

Interventions

cognitive rehabilitationBEHAVIORAL

computer training

Also known as: computer training
2
work therapyPROCEDURE

opportunity to work in carefully supervised hospital job

Also known as: IWT
1

Eligibility Criteria

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

You may qualify if:

  • diagnosis of schizophrenia or schizoaffective disorder

You may not qualify if:

  • change in psychiatric medications or housing within 30 days of study intake
  • episode of drug abuse within 30 days of study intake
  • GAF score 30 or less
  • known neurological disease or developmental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (9)

  • Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. doi: 10.1093/schbul/sbi038. Epub 2005 Aug 3.

    PMID: 16079390BACKGROUND

  • Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.

    PMID: 12823166RESULT

  • Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.

    PMID: 11483142RESULT

  • Fiszdon JM, Cardenas AS, Bryson GJ, Bell MD. Predictors of remediation success on a trained memory task. J Nerv Ment Dis. 2005 Sep;193(9):602-8. doi: 10.1097/01.nmd.0000177790.23311.ba.

    PMID: 16131943RESULT

  • Fiszdon JM, Whelahan H, Bryson GJ, Wexler BE, Bell MD. Cognitive training of verbal memory using a dichotic listening paradigm: impact on symptoms and cognition. Acta Psychiatr Scand. 2005 Sep;112(3):187-93. doi: 10.1111/j.1600-0447.2005.00565.x.

    PMID: 16095473RESULT

  • Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.

    PMID: 15870612RESULT

  • Bell MD, Bryson GJ, Greig TC, Fiszdon JM, Wexler BE. Neurocognitive enhancement therapy with work therapy: Productivity outcomes at 6- and 12-month follow-ups. J Rehabil Res Dev. 2005 Nov-Dec;42(6):829-38. doi: 10.1682/jrrd.2005.03.0061.

    PMID: 16680620RESULT

  • Fiszdon JM, Choi J, Bryson GJ, Bell MD. Impact of intellectual status on response to cognitive task training in patients with schizophrenia. Schizophr Res. 2006 Oct;87(1-3):261-9. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.

    PMID: 16737798RESULT

  • Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.

    PMID: 16571581RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Morris D Bell, Ph.D.

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 2, 2007

Study Start

October 1, 2000

Primary Completion

October 1, 2005

Study Completion

October 1, 2015

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

US(1)