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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

119 participants

Primary outcome timeframe

~12 weeks

Results posted on

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

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

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 weeks

Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely).

Outcome measures

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Investigators 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

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 weeks

Cognitive 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Executive Functioning Training

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

David Vance, PhD, University Professor

University of Alabama at Birmingham

Phone: 205-934-7589

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place