Trial Outcomes & Findings for Executive Functioning Training Study (NCT NCT05598047)
NCT ID: NCT05598047
Last Updated: 2026-05-20
Results Overview
Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely).
COMPLETED
PHASE2
119 participants
~12 weeks
2026-05-20
Participant Flow
Participants were recruited from our university HIV/AIDS clinic. They were screened over the phone to ascertain if they met some basic entry criteria (i.e., had HIV, living within 60 miles from the center, not homeless, no significant neuromedical comorbidities, not legally blind/deaf, not currently undergoing radiation or chemotherapy, no history of severe head trauma). Participants were compensated for their time. Recruitment occurred from 6/14/2023 to 2/14/2025.
Participant milestones
| Measure |
No-Contact Control Group
These participants will not receive any intervention.
|
Executive Functioning Training
BrainHQ (POSIT Science Inc.) computerized cognitive training modules were used as in our other studies; but these focused on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
|
Overall Study
COMPLETED
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Executive Functioning Training Study
Baseline characteristics by cohort
| Measure |
Executive Functioning Training
n=60 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
n=59 Participants
These participants will not receive any intervention.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.02 years
n=30 Participants
|
54.93 years
n=30 Participants
|
53.97 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
33 Participants
n=30 Participants
|
63 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=30 Participants
|
26 Participants
n=30 Participants
|
56 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=30 Participants
|
53 Participants
n=30 Participants
|
103 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Baseline Assessment of Cognitive Training
|
7.00 score on a scale
STANDARD_DEVIATION 2.71 • n=30 Participants
|
6.53 score on a scale
STANDARD_DEVIATION 2.67 • n=30 Participants
|
6.76 score on a scale
STANDARD_DEVIATION 2.69 • n=60 Participants
|
PRIMARY outcome
Timeframe: ~12 weeksParticipants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely).
Outcome measures
| Measure |
Executive Functioning Training
n=47 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
n=50 Participants
These participants will not receive any intervention.
|
|---|---|---|
|
Self-Perceived Need for Cognitive Training
|
7.49 score on a scale
Interval 1.0 to 10.0
|
3.34 score on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: ~12 weeksPopulation: This question was not asked of those in the control group because it does not apply to them since they did not do the cognitive training.
Participants were asked how much they enjoyed the cognitive training (scale from 1=not at all to 5=extremely).
Outcome measures
| Measure |
Executive Functioning Training
n=47 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
These participants will not receive any intervention.
|
|---|---|---|
|
Cognitive Training Satisfaction
|
3.26 score on a scale
Standard Deviation 1.26
|
—
|
PRIMARY outcome
Timeframe: ~12 weeksPopulation: This question was not asked of those in the control group because it does not apply to them since they did not do the cognitive training.
Investigators administer a qualitative (i.e., open-ended responses) survey to assess what participants liked/disliked (i.e. preferences) about the training and how to improve it. These verbal responses were then coded into categories for those who were assigned to the EFT group.
Outcome measures
| Measure |
Executive Functioning Training
n=47 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
These participants will not receive any intervention.
|
|---|---|---|
|
Cognitive Training Preferences
Liked Better Cognition
|
19 participants
|
—
|
|
Cognitive Training Preferences
Liked the Challenge
|
14 participants
|
—
|
|
Cognitive Training Preferences
Liked the game itself
|
6 participants
|
—
|
|
Cognitive Training Preferences
Liked the Stimulation
|
3 participants
|
—
|
|
Cognitive Training Preferences
Disliked Repetition
|
14 participants
|
—
|
|
Cognitive Training Preferences
Disliked Boring
|
3 participants
|
—
|
|
Cognitive Training Preferences
Disliked It Being Too Long (time)
|
2 participants
|
—
|
|
Cognitive Training Preferences
Disliked Too Difficult
|
6 participants
|
—
|
PRIMARY outcome
Timeframe: From enrollment through completion on average around 12 weeksPopulation: This was not calculated for the control group because it does not apply to them since they did not do the cognitive training.
Investigators calculated the hours of training completed. Ranges will be from 0 to 20 hours (i.e., 0% to 100%).
Outcome measures
| Measure |
Executive Functioning Training
n=60 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
These participants will not receive any intervention.
|
|---|---|---|
|
Hours of Cognitive Training Completed
|
9.05 0 to 20 hours of training
Interval 0.0 to 20.0
|
—
|
PRIMARY outcome
Timeframe: From enrollment through completion on average around 12 weeksInvestigators calculated the attrition rate of the protocol as measured by those who completed a posttest assessment; this was the indicator that participants completed the study.
Outcome measures
| Measure |
Executive Functioning Training
n=60 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
n=59 Participants
These participants will not receive any intervention.
|
|---|---|---|
|
Attrition Rates (After Study Data Collection)
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: ~12 weeksCognitive Inconsistency (a type of cognitive intra-individual variability) was calculated with Variability (measures consistency of participants hit reaction times during the test) and Hit Rate Standard Deviation (measures consistency of response speed). These are measured in T scores; 50 indicates a population mean with a standard deviation of 10. Higher T scores indicate more inconsistency, which is considered a poorer cognitive indicator. There is no clinically relevant threshold.
Outcome measures
| Measure |
Executive Functioning Training
n=47 Participants
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
|
No-Contact Control Group
n=50 Participants
These participants will not receive any intervention.
|
|---|---|---|
|
Cognitive Inconsistency (Cognitive Intra-individual Variability)
Variability
|
50.31 T-score
Standard Deviation 17.65 • Interval 45.73 to 55.19
|
59.00 T-score
Standard Deviation 14.55 • Interval 54.13 to 63.4
|
|
Cognitive Inconsistency (Cognitive Intra-individual Variability)
Hit Rate Standard Deviation
|
53.94 T-score
Standard Deviation 13.16 • Interval 51.2 to 58.1
|
58.39 T-score
Standard Deviation 14.80 • Interval 54.42 to 61.05
|
Adverse Events
No-Contact Control Group
Executive Functioning Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Vance, PhD, University Professor
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place