Trial Outcomes & Findings for Cognitive Training in the Treatment of AUD (NCT NCT02664038)
NCT ID: NCT02664038
Last Updated: 2024-08-27
Results Overview
Heavy alcohol use over 90 days as verified by Time Line Follow-back or breathalyzer findings. Minimum = 0. Maximum = 90. Fewer days is better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
3 months of active treatment
Results posted on
2024-08-27
Participant Flow
Participant milestones
| Measure |
CRT+IDC
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
Computer arcade games for 13 weeks plus Individual Drug Counseling
12 computer arcade games for 13 weeks accessed through the same portal as the Cognitive Remediation exercises and formatted similarly.
|
|---|---|---|
|
13 Week
STARTED
|
29
|
30
|
|
13 Week
COMPLETED
|
21
|
16
|
|
13 Week
NOT COMPLETED
|
8
|
14
|
|
26 Week
STARTED
|
21
|
16
|
|
26 Week
COMPLETED
|
16
|
12
|
|
26 Week
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
CRT+IDC
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
Computer arcade games for 13 weeks plus Individual Drug Counseling
12 computer arcade games for 13 weeks accessed through the same portal as the Cognitive Remediation exercises and formatted similarly.
|
|---|---|---|
|
13 Week
Lost to Follow-up
|
7
|
14
|
|
13 Week
Withdrawal by Subject
|
1
|
0
|
|
26 Week
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Cognitive Training in the Treatment of AUD
Baseline characteristics by cohort
| Measure |
CRT+IDC
n=29 Participants
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=30 Participants
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.79 years
STANDARD_DEVIATION 9.41 • n=99 Participants
|
54.60 years
STANDARD_DEVIATION 10.07 • n=107 Participants
|
55.68 years
STANDARD_DEVIATION 9.73 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Lifetime Months of Alcohol Use
|
474.07 Months
STANDARD_DEVIATION 190.00 • n=99 Participants
|
436.71 Months
STANDARD_DEVIATION 141.51 • n=107 Participants
|
455.39 Months
STANDARD_DEVIATION 165.76 • n=206 Participants
|
|
Alcohol Use Days in Last 30 Days
|
5.25 Days
STANDARD_DEVIATION 7.87 • n=99 Participants
|
3.07 Days
STANDARD_DEVIATION 4.93 • n=107 Participants
|
4.14 Days
STANDARD_DEVIATION 6.57 • n=206 Participants
|
|
Alcohol Use Days in Last 90 Days
|
39.39 Days
STANDARD_DEVIATION 27.13 • n=99 Participants
|
32.24 Days
STANDARD_DEVIATION 23.92 • n=107 Participants
|
35.75 Days
STANDARD_DEVIATION 25.57 • n=206 Participants
|
|
Polysubstance Use Days in the Last 30 Days
|
.73 Days
STANDARD_DEVIATION 2.60 • n=99 Participants
|
.42 Days
STANDARD_DEVIATION 1.41 • n=107 Participants
|
.57 Days
STANDARD_DEVIATION 2.05 • n=206 Participants
|
|
Polysubstance Use Days in the Last 90 Days
|
6.22 Days
STANDARD_DEVIATION 16.47 • n=99 Participants
|
6.79 Days
STANDARD_DEVIATION 18.31 • n=107 Participants
|
6.51 Days
STANDARD_DEVIATION 17.39 • n=206 Participants
|
|
Service Connected Disability (Yes)
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Social Security Disability Income (Yes)
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Education (years)
|
13.31 years
STANDARD_DEVIATION 1.76 • n=99 Participants
|
13.27 years
STANDARD_DEVIATION 1.95 • n=107 Participants
|
13.29 years
STANDARD_DEVIATION 1.84 • n=206 Participants
|
|
Premorbid IQ Estimate (WTAR)
|
100.28 units on a scale
STANDARD_DEVIATION 12.6 • n=99 Participants
|
98.93 units on a scale
STANDARD_DEVIATION 13.3 • n=107 Participants
|
99.61 units on a scale
STANDARD_DEVIATION 12.95 • n=206 Participants
|
|
Overall Neurocognitive Composite Score
|
45.6 T Scores
STANDARD_DEVIATION 4.8 • n=99 Participants
|
44.3 T Scores
STANDARD_DEVIATION 6.4 • n=107 Participants
|
44.95 T Scores
STANDARD_DEVIATION 5.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months of active treatmentHeavy alcohol use over 90 days as verified by Time Line Follow-back or breathalyzer findings. Minimum = 0. Maximum = 90. Fewer days is better.
Outcome measures
| Measure |
CRT+IDC
n=29 Participants
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=30 Participants
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
|---|---|---|
|
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer
|
5.49 Days
Standard Deviation 10.85
|
3.0 Days
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: 30 days preceding 6 month follow-up, 3 months after active treatment.Days of heavy drinking days over 30 days adjusted for baseline 30 Day heavy drinking days prior to randomization. Minimum = 0. Maximum = 30. Fewer days is better.
Outcome measures
| Measure |
CRT+IDC
n=14 Participants
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=11 Participants
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
|---|---|---|
|
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer
|
1.67 units on a scale (Number of Days)
Standard Error 1.21
|
1.51 units on a scale (Number of Days)
Standard Error 1.11
|
SECONDARY outcome
Timeframe: 6 month follow-upChanges in self-ratings of alcohol craving from baseline to 6 months. Minimum score = 0. Maximum score = 30. Lower is better.
Outcome measures
| Measure |
CRT+IDC
n=29 Participants
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=30 Participants
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
|---|---|---|
|
Penn Alcohol Craving Scale
|
3.94 score on a scale
Standard Error 1.45
|
4.59 score on a scale
Standard Error 1.68
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsChanges from baseline on Neurocognitive Composite Score Minimum score = 30; Mean = 50 indicates the population mean with a standard deviation of 10; Maximum score = 70. Higher is better.
Outcome measures
| Measure |
CRT+IDC
n=29 Participants
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=30 Participants
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
|---|---|---|
|
Neurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)
|
48.15 score on a scale (T scores)
Standard Error 1.08
|
46.70 score on a scale (T scores)
Standard Error 1.08
|
POST_HOC outcome
Timeframe: 6 months after randomizationPopulation: Data was extracted from VA medical records and there were many participants who did not have sufficient information in their chart
Clinical Global Index Scale (1 to 7) with 1 being full recovery and total abstinence. Scores 3 and below represent good recovery. Lower scores are better.
Outcome measures
| Measure |
CRT+IDC
n=10 Participants
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=12 Participants
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
|---|---|---|
|
Clinical Global Index at 6 Months
|
3.00 units on a scale
Standard Error 1.91
|
3.28 units on a scale
Standard Error 2.35
|
Adverse Events
CRT+IDC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Computer Game Play+IDC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CRT+IDC
n=29 participants at risk
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
Computer Game Play+IDC
n=30 participants at risk
Computer arcade games for 13 weeks plus Individual Drug Counseling
Cognitive Remediation Training: Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
|
|---|---|---|
|
Psychiatric disorders
Admitted to emergency department for severe alcohol intoxication
|
0.00%
0/29 • 3 months
|
3.3%
1/30 • Number of events 1 • 3 months
|
Additional Information
Morris Bell, Ph.D., Senior Research Career Scientist
VA Connecticut Healthcare System
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place