Trial Outcomes & Findings for The Effects of Mixed Working Memory Training on Subsequent Training Gains Among Older Adults (NCT NCT05672771)
NCT ID: NCT05672771
Last Updated: 2024-03-28
Results Overview
Average change in working memory from pre- to posttest in z-score units ("standard unit change"). For each working memory measure (Reading Span, Lexical Decision Span, Category Span, Operation Span, and Count Span), the change in z-score units was calculated \[(posttest score - pretest score) / standard deviation of the scores at pretest)\]. The score reported is the mean of these 5 values. A z-score of 0 represents no change from pretest to posttest; the unit is the standard deviations of the sample at pretest (e.g., a score 0.5 would indicate a half standard deviation improvement in overall working memory). There is no agreed upon standard of clinical significance for improvement in working memory
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Change from baseline to 5-6 wks after pretest
Results posted on
2024-03-28
Participant Flow
Participant milestones
| Measure |
Different Mixed Condition (DM)
Training in both Lexical Decision Span and Category Span in Phase 1 (which are both different from the target task Reading Span in Phase 2).
Different Mixed Condition (DM): Participants engage in home-based training on two working memory tasks, both different from those in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Different Single Condition (DS)
Training in the Lexical Decision Span in Phase 1 (which is different from the target task Reading Span in Phase 2).
Different Single Condition (DS): Participants engage in home-based training on a working memory task that is different from that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Same Task (ST) Practice Control
Training in Reading Span task in Phase 1 (which is the same as target task in Phase 2).
Same Task (ST) Practice Control: Participants engage in home-based training on the exact same working memory tasks as that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Non-WM Placebo Control (PC)
Training in a speeded Lexical Decision task only (which has no memory component) in Phase 1 prior to Phase 2 training in WM.
Non-WM Placebo Control (PC): Participants engage in home-based training on speeded verbal decision, which unlike the target task training, has no memory component. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
25
|
22
|
22
|
|
Overall Study
COMPLETED
|
19
|
22
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Mixed Working Memory Training on Subsequent Training Gains Among Older Adults
Baseline characteristics by cohort
| Measure |
Different Mixed Condition (DM)
n=21 Participants
Training in both Lexical Decision Span and Category Span in Phase 1 (which are both different from the target task Reading Span in Phase 2).
Different Mixed Condition (DM): Participants engage in home-based training on two working memory tasks, both different from those in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Different Single Condition (DS)
n=25 Participants
Training in the Lexical Decision Span in Phase 1 (which is different from the target task Reading Span in Phase 2).
Different Single Condition (DS): Participants engage in home-based training on a working memory task that is different from that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Same Task (ST) Practice Control
n=22 Participants
Training in Reading Span task in Phase 1 (which is the same as target task in Phase 2).
Same Task (ST) Practice Control: Participants engage in home-based training on the exact same working memory tasks as that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Non-WM Placebo Control (PC)
n=22 Participants
Training in a speeded Lexical Decision task only (which has no memory component) in Phase 1 prior to Phase 2 training in WM.
Non-WM Placebo Control (PC): Participants engage in home-based training on speeded verbal decision, which unlike the target task training, has no memory component. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Age, Continuous
|
72.95 years
STANDARD_DEVIATION 6.34 • n=5 Participants
|
72.56 years
STANDARD_DEVIATION 6.32 • n=7 Participants
|
71.36 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
70.77 years
STANDARD_DEVIATION 6.76 • n=4 Participants
|
71.92 years
STANDARD_DEVIATION 6.77 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
00 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Working Memory Composite
|
0.10 z-score
STANDARD_DEVIATION 0.86 • n=5 Participants
|
-0.05 z-score
STANDARD_DEVIATION 0.77 • n=7 Participants
|
-0.01 z-score
STANDARD_DEVIATION 0.91 • n=5 Participants
|
-0.12 z-score
STANDARD_DEVIATION 0.55 • n=4 Participants
|
-0.02 z-score
STANDARD_DEVIATION 0.77 • n=21 Participants
|
|
Education Level
|
16.29 years
STANDARD_DEVIATION 2.10 • n=5 Participants
|
16.84 years
STANDARD_DEVIATION 2.21 • n=7 Participants
|
16.46 years
STANDARD_DEVIATION 1.84 • n=5 Participants
|
15.93 years
STANDARD_DEVIATION 2.17 • n=4 Participants
|
16.39 years
STANDARD_DEVIATION 2.08 • n=21 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 5-6 wks after pretestPopulation: Numbers of participants (N=80) differ from baseline (N=90) because 10 participants declined to continue the research activities.
Average change in working memory from pre- to posttest in z-score units ("standard unit change"). For each working memory measure (Reading Span, Lexical Decision Span, Category Span, Operation Span, and Count Span), the change in z-score units was calculated \[(posttest score - pretest score) / standard deviation of the scores at pretest)\]. The score reported is the mean of these 5 values. A z-score of 0 represents no change from pretest to posttest; the unit is the standard deviations of the sample at pretest (e.g., a score 0.5 would indicate a half standard deviation improvement in overall working memory). There is no agreed upon standard of clinical significance for improvement in working memory
Outcome measures
| Measure |
Different Mixed Condition (DM)
n=19 Participants
Training in both Lexical Decision Span and Category Span in Phase 1 (which are both different from the target task Reading Span in Phase 2).
Different Mixed Condition (DM): Participants engage in home-based training on two working memory tasks, both different from those in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Different Single Condition (DS)
n=22 Participants
Training in the Lexical Decision Span in Phase 1 (which is different from the target task Reading Span in Phase 2).
Different Single Condition (DS): Participants engage in home-based training on a working memory task that is different from that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Same Task (ST) Practice Control
n=21 Participants
Training in Reading Span task in Phase 1 (which is the same as target task in Phase 2).
Same Task (ST) Practice Control: Participants engage in home-based training on the exact same working memory tasks as that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Non-WM Placebo Control (PC)
n=18 Participants
Training in a speeded Lexical Decision task only (which has no memory component) in Phase 1 prior to Phase 2 training in WM.
Non-WM Placebo Control (PC): Participants engage in home-based training on speeded verbal decision, which unlike the target task training, has no memory component. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
|---|---|---|---|---|
|
Change in Overall Working Memory
|
0.42 Standard unit change
Standard Deviation 1.40
|
0.26 Standard unit change
Standard Deviation 0.66
|
-0.01 Standard unit change
Standard Deviation 0.57
|
0.04 Standard unit change
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: Change from Baseline to 5-6 weeks after pretestPopulation: Numbers of participants (N=80) differ from baseline (N=90) because 10 participants declined to continue the research activities.
Change in Reading Span score from pre- to posttest in z-score units ("standard unit change"). The change in z-score units was calculated \[(posttest score - pretest score) / standard deviation of the scores at pretest)\]. A z-score of 0 represents no change from pretest to posttest; the unit is the standard deviations of the sample at pretest (e.g., a score 0.5 would indicate a half standard deviation improvement in overall working memory). There is no agreed upon standard of clinical significance for improvement in working memory
Outcome measures
| Measure |
Different Mixed Condition (DM)
n=21 Participants
Training in both Lexical Decision Span and Category Span in Phase 1 (which are both different from the target task Reading Span in Phase 2).
Different Mixed Condition (DM): Participants engage in home-based training on two working memory tasks, both different from those in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Different Single Condition (DS)
n=22 Participants
Training in the Lexical Decision Span in Phase 1 (which is different from the target task Reading Span in Phase 2).
Different Single Condition (DS): Participants engage in home-based training on a working memory task that is different from that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Same Task (ST) Practice Control
n=21 Participants
Training in Reading Span task in Phase 1 (which is the same as target task in Phase 2).
Same Task (ST) Practice Control: Participants engage in home-based training on the exact same working memory tasks as that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Non-WM Placebo Control (PC)
n=18 Participants
Training in a speeded Lexical Decision task only (which has no memory component) in Phase 1 prior to Phase 2 training in WM.
Non-WM Placebo Control (PC): Participants engage in home-based training on speeded verbal decision, which unlike the target task training, has no memory component. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
|---|---|---|---|---|
|
Change in Reading Span
|
0.70 standard unit change
Standard Deviation 0.66
|
0.06 standard unit change
Standard Deviation 0.85
|
-0.03 standard unit change
Standard Deviation 0.77
|
0.14 standard unit change
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Numbers of participants (N=80) differ from baseline (N=90) because 10 participants declined to continue the research activities.
In Phase 2, training data on the target task (Reading Span) is collected over 10 days. Training gains are estimated by the coefficients for the condition contrast by training interaction in a linear mixed effects model, in which mean working memory score across training days was modeled as a function of the Phase 1 training condition. Using the lme4 and lmerTest packages for R version 4.2.2, a mixed-effects linear regression model was employed to model the mean daily span score with condition and training day as the fixed factors, and a by-subject random intercept, using the restricted maximum likelihood (REML) method of estimation.
Outcome measures
| Measure |
Different Mixed Condition (DM)
n=19 Participants
Training in both Lexical Decision Span and Category Span in Phase 1 (which are both different from the target task Reading Span in Phase 2).
Different Mixed Condition (DM): Participants engage in home-based training on two working memory tasks, both different from those in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Different Single Condition (DS)
n=21 Participants
Training in the Lexical Decision Span in Phase 1 (which is different from the target task Reading Span in Phase 2).
Different Single Condition (DS): Participants engage in home-based training on a working memory task that is different from that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Same Task (ST) Practice Control
n=20 Participants
Training in Reading Span task in Phase 1 (which is the same as target task in Phase 2).
Same Task (ST) Practice Control: Participants engage in home-based training on the exact same working memory tasks as that in the target task training. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
Non-WM Placebo Control (PC)
n=17 Participants
Training in a speeded Lexical Decision task only (which has no memory component) in Phase 1 prior to Phase 2 training in WM.
Non-WM Placebo Control (PC): Participants engage in home-based training on speeded verbal decision, which unlike the target task training, has no memory component. Goal is 10 days of training, with 4 8-min blocks of training each day.
|
|---|---|---|---|---|
|
Training Gains on the Reading Span Task in Phase 2
|
.021 coefficient
Standard Error .011
|
.034 coefficient
Standard Error .010
|
.021 coefficient
Standard Error .010
|
0 coefficient
Standard Error 0
|
Adverse Events
Different Mixed Condition (DM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Different Single Condition (DS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Same Task (ST) Practice Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-WM Placebo Control (PC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place