NCT00339170

Brief Summary

This study will evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2000

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 30, 2020

Status Verified

April 1, 2016

Enrollment Period

13.2 years

First QC Date

June 16, 2006

Last Update Submit

March 27, 2020

Conditions

Schizophrenia

Keywords

Schizoaffective DisorderSchizophrenic DisordersPsychotic DisordersCognition

Outcome Measures

Primary Outcomes (6)

  • Schizophrenia symptoms

    Measured at Year 1

  • Vocational functioning

    Measured at Year 2

  • Schizophrenia symptoms

    Measured at Year 2

  • Quality of life

    Measured at Year 2

  • Quality of life

    Measured at Year 1

  • Vocational functioning

    Measured at Year 1

Secondary Outcomes (4)

  • Number of hospitalizations

    Measured at Year 1

  • Income

    Measured at Year 1

  • Number of hospitalizations

    Measured at Year 2

  • Income

    Measured at Year 2

Study Arms (2)

1

EXPERIMENTAL

Participants receive a 12-month cognitive enhancement training program plus a 12-month work therapy program.

Behavioral: Computer-Based Cognitive Enhancement Training ProgramBehavioral: Work Therapy Program

2

ACTIVE COMPARATOR

Participants receive a 12-month work therapy program alone.

Behavioral: Work Therapy Program

Interventions

Computer-Based Cognitive Enhancement Training ProgramBEHAVIORAL

Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing.

1
Work Therapy ProgramBEHAVIORAL

Participants in the work therapy program will attend two non-cognitive discussion groups per week.

12

Eligibility Criteria

Age20 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:

  • Hospitalized in the 30 days prior to study entry
  • Homeless in the 30 days prior to study entry
  • Changed medications in the 30 days prior to study entry
  • Substance abuse in the 30 days prior to study entry
  • History of head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (11)

  • Bell, M.D., Bryson, G., Kaplan, E. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 1999; 36:322.

    BACKGROUND

  • 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: 12823166BACKGROUND

  • 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: 11483142BACKGROUND

  • 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: 16571581BACKGROUND

  • Greig T, Zito W, Bell MD. Rehab rounds: A hybrid transitional and supported employment program. Psychiatr Serv. 2004 Mar;55(3):240-2. doi: 10.1176/appi.ps.55.3.240. No abstract available.

    PMID: 15001722BACKGROUND

  • Bell, M.D., Brsyon, G.J. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 2001;36:322.

    BACKGROUND

  • Bell, M.D, Brsyon, G.J , Fiszdon, J., Greig, T.C., Wexler, B.E. Neurocognitive enhancement therapy and work therapy in schizophrenia: Work outcomes at 6 months and 12 month follow-up. Biological Psychiatry. 2004; 55: 1S-242S.

    BACKGROUND

  • Greig, T.C., Nicholls, S.S., Bryson, G.J., Bell, M.D. The Vocational Cognitive Rating Scale: A Scale for the Assessment of Cognitive Functioning at Work for Clients With Severe Mental Illness. The Journal of Vocational Rehabilitation. 2004; 21: 71-81.

    BACKGROUND

  • Bryson, G & Bell, MD. Work performance improvement in schizophrenia: Symptom and cognitive predictors. Schizophrenia Resarch. 2001; 49: 258.

    BACKGROUND

  • Bell MD, Choi KH, Dyer C, Wexler BE. Benefits of cognitive remediation and supported employment for schizophrenia patients with poor community functioning. Psychiatr Serv. 2014 Apr 1;65(4):469-75. doi: 10.1176/appi.ps.201200505.

    PMID: 24382594DERIVED

  • Surti TS, Corbera S, Bell MD, Wexler BE. Successful computer-based visual training specifically predicts visual memory enhancement over verbal memory improvement in schizophrenia. Schizophr Res. 2011 Nov;132(2-3):131-4. doi: 10.1016/j.schres.2011.06.031. Epub 2011 Jul 27.

    PMID: 21795025DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Morris D. Bell, PhD

    Yale University School of Medicine, VA CT Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

April 1, 2000

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

March 30, 2020

Record last verified: 2016-04

Locations

US(1)