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Completed

NCT Number: NCT00339170

Cognitive Training and Enhanced Supported Employment in Schizophrenia

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Based Cognitive Enhancement Training Program

Behavioral

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.

Work Therapy Program

Behavioral

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

Primary outcomes

  1. Schizophrenia symptoms

    Time frame: Measured at Year 1

  2. Vocational functioning

    Time frame: Measured at Year 2

  3. Schizophrenia symptoms

    Time frame: Measured at Year 2

  4. Quality of life

    Time frame: Measured at Year 2

  5. Quality of life

    Time frame: Measured at Year 1

  6. Vocational functioning

    Time frame: Measured at Year 1

Secondary outcomes

  1. Number of hospitalizations

    Time frame: Measured at Year 1

  2. Income

    Time frame: Measured at Year 1

  3. Number of hospitalizations

    Time frame: Measured at Year 2

  4. Income

    Time frame: Measured at Year 2

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Training and Enhanced Supported Employment

Important dates

Study start
2000
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2006
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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