Cognitive Training and Enhanced Supported Employment in Schizophrenia

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.

Official Title
-----------------
Cognitive Training and Enhanced Supported Employment

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Computer-Based Cognitive Enhancement Training Program
* Behavioral: Work Therapy Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants receive a 12-month cognitive enhancement training program plus a 12-month work therapy program. | Behavioral: Computer-Based Cognitive Enhancement Training Program<br>* 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.<br>Behavioral: Work Therapy Program<br>* Participants in the work therapy program will attend two non-cognitive discussion groups per week.<br>|
| Active Comparator: 2<br>Participants receive a 12-month work therapy program alone. | Behavioral: Work Therapy Program<br>* Participants in the work therapy program will attend two non-cognitive discussion groups per week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalizations |  | Measured at Year 1 | 
| Income |  | Measured at Year 1 | 
| Number of hospitalizations |  | Measured at Year 2 | 
| Income |  | Measured at Year 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychotic Disorders, Schizoaffective Disorder, Schizophrenic Disorders, Cognition