Trial Outcomes & Findings for Project IMPACT: Improving Memory Performance by Applying Cognitive Training (NCT NCT02909101)
NCT ID: NCT02909101
Last Updated: 2019-10-30
Results Overview
Measured by domain deficit score, which is a continuous measure of overall impairment on the domain. 0 means no impairment and 5 means highest possible impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline; post-training, approximately 8 weeks
Results posted on
2019-10-30
Participant Flow
Participant milestones
| Measure |
Active Cognitive Training (ACT)
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Active Cognitive Training (ACT)
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Project IMPACT: Improving Memory Performance by Applying Cognitive Training
Baseline characteristics by cohort
| Measure |
Active Cognitive Training (ACT)
n=29 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=29 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
Total
n=58 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
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.97 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
48.28 years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
48.62 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Wechsler Test of Adult Reading (WTAR)
|
81.97 units on a scale
STANDARD_DEVIATION 14.47 • n=5 Participants
|
83.14 units on a scale
STANDARD_DEVIATION 13.75 • n=7 Participants
|
82.55 units on a scale
STANDARD_DEVIATION 14.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; post-training, approximately 8 weeksMeasured by domain deficit score, which is a continuous measure of overall impairment on the domain. 0 means no impairment and 5 means highest possible impairment.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=28 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=28 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Working Memory Assessed by Domain Deficit Score
Baseline
|
.29 Score on a scale
Standard Error .09
|
.21 Score on a scale
Standard Error .09
|
|
Working Memory Assessed by Domain Deficit Score
Post-training
|
.14 Score on a scale
Standard Error .07
|
.26 Score on a scale
Standard Error .07
|
SECONDARY outcome
Timeframe: Baseline; post-training, approximately 8 weeksPopulation: One participant from ACT and two participants from CON were excluded because they did not provide valid responses on the MCQ at the post-training follow-up.
The Monetary Choice Questionnaire (MCQ) is a standardized delay discounting task. Because scores are on a logarithmic scale, they were rank ordered for analysis. Ranks range from 1 to 13, with higher ranks meaning higher impulsivity.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=27 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=26 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Baseline
|
8.70 score on a scale
Standard Error .41
|
7.97 score on a scale
Standard Error .42
|
|
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Post-training
|
8.38 score on a scale
Standard Error .37
|
8.76 score on a scale
Standard Error .38
|
SECONDARY outcome
Timeframe: Post-training, approximately 8 weeksParticipants rated how satisfied they found the intervention on a 5 point scale (with 1 being very dissatisfied and 5 being very satisfied). Acceptability was defined a priori of achieving a mean rating of \>3.5 on the 5 point scale.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=28 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=28 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Acceptability as Measured by Participant Ratings
|
4.04 score on a scale
Standard Deviation 1.32
|
4.14 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Post-training, approximately 8 weeksParticipants rated how helpful they found the intervention on a 5 point scale (with 1 being very unhelpful and 5 being very helpful). Acceptability was defined a priori of achieving a mean rating of \>3.5 on the 5 point scale for helpfulness.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=28 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=28 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions
|
4.14 score on a scale
Standard Deviation 1.15
|
4.04 score on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline; post-training, approximately 8 weeks0% indicates no doses of medications were taken, and 100% means all doses were taken.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=28 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=28 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Percent Medication Adherence Across All Antiretroviral Medications
Baseline
|
96.53 percentage of doses
Standard Error 2.29
|
88.97 percentage of doses
Standard Error 2.29
|
|
Percent Medication Adherence Across All Antiretroviral Medications
Post-training
|
96.08 percentage of doses
Standard Error 2.19
|
92.03 percentage of doses
Standard Error 2.19
|
SECONDARY outcome
Timeframe: Baseline; post-training, approximately 8 weeksThe RAB is a standardized survey. Scores range from 0 to 18, with higher scores meaning greater sexual risk.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=28 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=28 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)
Baseline
|
4.53 score on a scale
Standard Error .43
|
3.68 score on a scale
Standard Error .43
|
|
Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)
Post-training
|
4.04 score on a scale
Standard Error .47
|
4.21 score on a scale
Standard Error .47
|
SECONDARY outcome
Timeframe: Baseline; post-training, approximately 8 weeksThe Timeline Followback Method involves asking subjects to retrospectively estimate their cocaine use 30 days prior to the interview date. Responses therefore range from 0 to 30 days.
Outcome measures
| Measure |
Active Cognitive Training (ACT)
n=28 Participants
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games
|
Control Training (CON)
n=28 Participants
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games
|
|---|---|---|
|
Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology
Post-training
|
8.49 days
Standard Error 1.72
|
5.12 days
Standard Error 1.72
|
|
Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology
Baseline
|
7.51 days
Standard Error 1.68
|
6.88 days
Standard Error 1.68
|
Adverse Events
Active Cognitive Training (ACT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Training (CON)
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