Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.
Interventions
BEHAVIORALCognitive Remediation
This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months.
BEHAVIORALComputer Skills
This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months.
Sponsors
Veterans Medical Research Foundation
Minneapolis Veterans Affairs Medical Center
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Veterans with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder * No hospitalizations in the previous 4 weeks * No antipsychotic medication changes in the previous 4 weeks * Age 18-60 * Does not meet DSM-IV criteria for substance dependence in the previous 6 months or substance abuse in the previous month
Exclusion criteria
* History of clinically significant head injury or neurological disease * Poor comprehension of the English language * History of diagnosis of mental retardation or pervasive developmental disorder * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Assessment - MATRICS Consensus Cognitive Battery | Post-intervention, within 2 weeks of completion of the 4 month intervention | The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity - University of California, San Diego Performance-Based Skills Assessment | Post-intervention, within 2 weeks of completion of the 4 month intervention | The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better. |
Countries
United States
Participant flow
Recruitment details
86 individuals were enrolled in the study. However, prior to condition assignment, 3 participants indicated that they needed to withdraw due to transportation problems, 1 participant withdrew due to a medical condition, and 1 participant lost interest in the study. Therefore, 81 participants were randomized to a study condition.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Remediation A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.
Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months. | 40 |
| Computer Skills This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.
Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months. | 41 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Cognitive Remediation | Computer Skills | Total |
|---|---|---|---|
| Age, Continuous | 45.83 years STANDARD_DEVIATION 9.08 | 46.73 years STANDARD_DEVIATION 10.24 | 46.28 years STANDARD_DEVIATION 9.63 |
| Region of Enrollment United States | 40 participants | 41 participants | 81 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 20 Participants |
| Sex: Female, Male Male | 33 Participants | 28 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 40 | 3 / 41 |
| serious Total, serious adverse events | 7 / 40 | 7 / 41 |
Outcome results
Primary
Cognitive Assessment - MATRICS Consensus Cognitive Battery
The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.
Time frame: Post-intervention, within 2 weeks of completion of the 4 month intervention
Population: All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | Cognitive Assessment - MATRICS Consensus Cognitive Battery | MATRICS Working Memory Index | 40.08 T-score | Standard Deviation 11.95 |
| Cognitive Remediation | Cognitive Assessment - MATRICS Consensus Cognitive Battery | MATRICS Attention Index | 39.80 T-score | Standard Deviation 10.82 |
| Computer Skills | Cognitive Assessment - MATRICS Consensus Cognitive Battery | MATRICS Working Memory Index | 43.28 T-score | Standard Deviation 11.8 |
| Computer Skills | Cognitive Assessment - MATRICS Consensus Cognitive Battery | MATRICS Attention Index | 41.28 T-score | Standard Deviation 10.11 |
Comparison: MATRICS Working Memory Indexp-value: 0.06ANOVA
Comparison: MATRICS Attention Indexp-value: 0.09ANOVA
Secondary
Functional Capacity - University of California, San Diego Performance-Based Skills Assessment
The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.
Time frame: Post-intervention, within 2 weeks of completion of the 4 month intervention
Population: All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Functional Capacity - University of California, San Diego Performance-Based Skills Assessment | 79.03 units on a scale | Standard Deviation 10.6 |
| Computer Skills | Functional Capacity - University of California, San Diego Performance-Based Skills Assessment | 78.78 units on a scale | Standard Deviation 10.29 |
p-value: 0.73ANOVA