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Cognitive Training and Enhanced Supported Employment in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-Based Cognitive Enhancement Training Program
Work Therapy Program
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizoaffective Disorder, Schizophrenic Disorders, Psychotic Disorders, Cognition

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: 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

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Participants receive a 12-month work therapy program alone.

Outcomes

Primary Outcome Measures

Schizophrenia symptoms
Vocational functioning
Schizophrenia symptoms
Quality of life
Quality of life
Vocational functioning

Secondary Outcome Measures

Number of hospitalizations
Income
Number of hospitalizations
Income

Full Information

First Posted
June 16, 2006
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00339170
Brief Title
Cognitive Training and Enhanced Supported Employment in Schizophrenia
Official Title
Cognitive Training and Enhanced Supported Employment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.
Detailed Description
Schizophrenia is a chronic, severe, and disabling brain disorder that affects 2.4 million people in the United States. Individuals with schizophrenia may have difficulties with cognitive functioning, including problems with attention, memory, and organizational thought processes. These factors can lead to decreased productivity and poor work performance, which may make holding a job difficult. Research has shown that certain types of psychological therapies, such as cognitive behavioral therapy, are useful in reducing the severity of schizophrenic symptoms. The purpose of this study is to determine whether a computer-based cognitive enhancement training program, in combination with a work therapy program, will enhance workplace performance, productivity, and quality of life in individuals with schizophrenia. This study will enroll individuals with schizophrenia or schizoaffective disorder. Participants will undergo a cognitive assessment at baseline. They will then be randomly assigned to either a 12-month cognitive enhancement training program plus a 12-month work therapy program or a 12-month work therapy program alone. 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. Individuals taking part only in the work therapy program will attend two non-cognitive discussion groups per week. All participants will work up to 20 hours a week in an approved work environment, and will have access to appropriate support services. Following the end of the program, participants will have the option of working an additional 12 months. Schizophrenia symptoms, quality of life, and neuropsychological and rehabilitation effects will be assessed at the end of Years 1 and 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizoaffective Disorder, Schizophrenic Disorders, Psychotic Disorders, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants receive a 12-month cognitive enhancement training program plus a 12-month work therapy program.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants receive a 12-month work therapy program alone.
Intervention Type
Behavioral
Intervention Name(s)
Computer-Based Cognitive Enhancement Training Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Work Therapy Program
Intervention Description
Participants in the work therapy program will attend two non-cognitive discussion groups per week.
Primary Outcome Measure Information:
Title
Schizophrenia symptoms
Time Frame
Measured at Year 1
Title
Vocational functioning
Time Frame
Measured at Year 2
Title
Schizophrenia symptoms
Time Frame
Measured at Year 2
Title
Quality of life
Time Frame
Measured at Year 2
Title
Quality of life
Time Frame
Measured at Year 1
Title
Vocational functioning
Time Frame
Measured at Year 1
Secondary Outcome Measure Information:
Title
Number of hospitalizations
Time Frame
Measured at Year 1
Title
Income
Time Frame
Measured at Year 1
Title
Number of hospitalizations
Time Frame
Measured at Year 2
Title
Income
Time Frame
Measured at Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris D. Bell, PhD
Organizational Affiliation
Yale University School of Medicine, VA CT Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Bell, M.D., Bryson, G., Kaplan, E. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 1999; 36:322.
Results Reference
background
PubMed Identifier
12823166
Citation
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.
Results Reference
background
PubMed Identifier
11483142
Citation
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.
Results Reference
background
PubMed Identifier
16571581
Citation
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.
Results Reference
background
PubMed Identifier
15001722
Citation
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.
Results Reference
background
Citation
Bell, M.D., Brsyon, G.J. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 2001;36:322.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Bryson, G & Bell, MD. Work performance improvement in schizophrenia: Symptom and cognitive predictors. Schizophrenia Resarch. 2001; 49: 258.
Results Reference
background
PubMed Identifier
24382594
Citation
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.
Results Reference
derived
PubMed Identifier
21795025
Citation
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.
Results Reference
derived

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Cognitive Training and Enhanced Supported Employment in Schizophrenia

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