Trial Outcomes & Findings for Remediation of Working Memory in Schizophrenia (NCT NCT00995553)
NCT ID: NCT00995553
Last Updated: 2016-04-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Post-intervention, within 2 weeks of completion of the 4 month intervention
Results posted on
2016-04-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
Baseline Characteristics
Remediation of Working Memory in Schizophrenia
Baseline characteristics by cohort
| Measure |
Cognitive Remediation
n=40 Participants
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.
|
Computer Skills
n=41 Participants
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.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.83 years
STANDARD_DEVIATION 9.08 • n=39 Participants
|
46.73 years
STANDARD_DEVIATION 10.24 • n=41 Participants
|
46.28 years
STANDARD_DEVIATION 9.63 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
61 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
41 participants
n=41 Participants
|
81 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Post-intervention, within 2 weeks of completion of the 4 month interventionPopulation: 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.
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.
Outcome measures
| Measure |
Cognitive Remediation
n=40 Participants
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.
|
Computer Skills
n=40 Participants
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.
|
|---|---|---|
|
Cognitive Assessment - MATRICS Consensus Cognitive Battery
MATRICS Working Memory Index
|
40.08 T-score
Standard Deviation 11.95
|
43.28 T-score
Standard Deviation 11.80
|
|
Cognitive Assessment - MATRICS Consensus Cognitive Battery
MATRICS Attention Index
|
39.80 T-score
Standard Deviation 10.82
|
41.28 T-score
Standard Deviation 10.11
|
SECONDARY outcome
Timeframe: Post-intervention, within 2 weeks of completion of the 4 month interventionPopulation: 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.
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.
Outcome measures
| Measure |
Cognitive Remediation
n=40 Participants
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.
|
Computer Skills
n=40 Participants
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.
|
|---|---|---|
|
Functional Capacity - University of California, San Diego Performance-Based Skills Assessment
|
79.03 units on a scale
Standard Deviation 10.60
|
78.78 units on a scale
Standard Deviation 10.29
|
Adverse Events
Cognitive Remediation
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Computer Skills
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Remediation
n=40 participants at risk
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.
|
Computer Skills
n=41 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
17.5%
7/40 • Number of events 15
|
17.1%
7/41 • Number of events 9
|
Other adverse events
| Measure |
Cognitive Remediation
n=40 participants at risk
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.
|
Computer Skills
n=41 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Temporary symptom increase not requiring hospitalization
|
7.5%
3/40 • Number of events 4
|
7.3%
3/41 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place