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Clinical Trials/NCT00339170
NCT00339170CompletedNot Applicable

Cognitive Training and Enhanced Supported Employment

Yale University1 site in 1 country98 target enrollmentStarted: April 1, 2000Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
98
Locations
1
Primary Endpoint
Schizophrenia symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

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

Intervention: Computer-Based Cognitive Enhancement Training Program (Behavioral)

1

Experimental

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

Intervention: Work Therapy Program (Behavioral)

2

Active Comparator

Participants receive a 12-month work therapy program alone.

Intervention: Work Therapy Program (Behavioral)

Outcomes

Primary Outcomes

Schizophrenia symptoms

Time Frame: Measured at Year 2

Vocational functioning

Time Frame: Measured at Year 1

Quality of life

Time Frame: Measured at Year 1

Schizophrenia symptoms

Time Frame: Measured at Year 1

Vocational functioning

Time Frame: Measured at Year 2

Quality of life

Time Frame: Measured at Year 2

Secondary Outcomes

  • Number of hospitalizations(Measured at Year 2)
  • Income(Measured at Year 2)
  • Number of hospitalizations(Measured at Year 1)
  • Income(Measured at Year 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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