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Cognitive Training in the Treatment of AUD

Cognitive Training in the Treatment of Alcohol Use Disorders in Older Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02664038
Enrollment
59
Registered
2016-01-26
Start date
2016-08-22
Completion date
2022-06-30
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder Cognitive Decline

Keywords

AUD, Neuropsychology, Cognitive Remediation

Brief summary

Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive function) reduce ability to benefit from current treatments. These cognitive impairments are especially common in the early phase of recovery, persist over years and get worse with age. Recent research suggests that cognitive remediation therapy (CRT) may improve attention, memory and executive function in other disorders, and the investigators just completed pilot study with AUD Veterans found significantly greater improvements for those receiving CRT. The proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined with a standardized alcohol treatment. The investigators hypothesize that CRT will improve neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will determine whether CRT augmentation can benefit Veterans with AUDs.

Detailed description

This study aims to determine whether a combined intervention of cognitive remediation therapy (CRT) and Individual Drug Counseling (IDC) can benefit older Veterans in the initial phase of alcohol abuse treatment by improving abstinence outcomes and neurocognition. Substantial cognitive impairment is associated with alcohol use disorders (AUD), and becomes worse with years of use and the aging processes. In particular, Veterans entering treatment for AUD display cognitive deficits that may reduce their ability to benefit from treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, learning and memory and executive function are common. Since treatment requires that the individual be able to sustain attention, remember what is learned, and apply it to recovery, impaired underlying cognitive processes make successful treatment less likely. Moreover, problems with executive functioning and other pre-frontal cognitive processes have been associated with decreased treatment retention and poorer AUD treatment outcomes. Although cognition can improve with sustained abstinence, it is during the early phase of recovery, when cognition is most impaired, that patients receive the most intensive treatment. AUD is a major cause of suffering and functional disability for older Veterans and a common co-morbidity with other physical and mental disorders. Finding more effective treatments of AUD remains a priority for VA healthcare. The purpose of the proposed study is to learn whether CRT plus IDC, an evidence-based outpatient AUD treatment is more effective than a Game-Play Placebo plus IDC. Game-Play Placebo has been used to provide equipoise between conditions in other CRT studies and in a current CRT study with mTBI Veterans funded by DoD being conducted by the PI. The current study is a randomized controlled trial (RCT) with a target enrollment of 90 Veterans in the initial phase of AUD treatment. The study is sufficiently powered to allow us to fulfill the following aims and test their related hypotheses: Specific Primary Aim # 1: To determine if CRT+IDC is more effective than Game-Play Placebo +IDC in decreasing alcohol use in older Veterans during the 3 month active intervention period. Ho1: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method (TLFB) during the 90 days of active intervention. Secondary Aim #1: To determine if CRT+IDC is more effective than Game-Play Placebo+ IDC in sustaining decreased alcohol use in older Veterans at the end of 6 months (3 months after the active intervention period). Ho2: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method (TLFB) for the 30 days preceding 6 month follow-up. Secondary Aim #2: To determine if the combination of CRT and IDC is more effective than game play placebo and IDC in improving neurocognitive functioning. Ho3: Veterans receiving CRT+IDC will show greater improvement than Veterans receiving Game-Play Placebo+IDC at 3 month follow-up on a global index of neurocognitive function, and on an index of working memory and an index of executive function. Ho4: Differential improvements in neurocognitive function will be sustained at 6 month follow-up.

Interventions

Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Veterans enrolled in VA AUD treatment as usual and Non-Veteran community members in AUD treatment * Have a primary diagnosis of AUD and are within 30 days of detoxification or last use at time of recruitment

Exclusion criteria

* Other medical illnesses that compromise neurocognition * Active use of prescribed opioids or benzodiazepines that may hinder new learning * Commitment to complete active phase and attend follow-up * No pending incarceration or plans to leave the state

Design outcomes

Primary

MeasureTime frameDescription
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer3 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.

Secondary

MeasureTime frameDescription
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer30 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.
Penn Alcohol Craving Scale6 month follow-upChanges in self-ratings of alcohol craving from baseline to 6 months. Minimum score = 0. Maximum score = 30. Lower is better.
Neurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
29
Computer Game Play+IDC
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
30
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001
13 WeekLost to Follow-up714
13 WeekWithdrawal by Subject10
26 WeekLost to Follow-up54

Baseline characteristics

CharacteristicComputer Game Play+IDCCRT+IDCTotal
Age, Continuous54.60 years
STANDARD_DEVIATION 10.07
56.79 years
STANDARD_DEVIATION 9.41
55.68 years
STANDARD_DEVIATION 9.73
Alcohol Use Days in Last 30 Days3.07 Days
STANDARD_DEVIATION 4.93
5.25 Days
STANDARD_DEVIATION 7.87
4.14 Days
STANDARD_DEVIATION 6.57
Alcohol Use Days in Last 90 Days32.24 Days
STANDARD_DEVIATION 23.92
39.39 Days
STANDARD_DEVIATION 27.13
35.75 Days
STANDARD_DEVIATION 25.57
Education (years)13.27 years
STANDARD_DEVIATION 1.95
13.31 years
STANDARD_DEVIATION 1.76
13.29 years
STANDARD_DEVIATION 1.84
Lifetime Months of Alcohol Use436.71 Months
STANDARD_DEVIATION 141.51
474.07 Months
STANDARD_DEVIATION 190
455.39 Months
STANDARD_DEVIATION 165.76
Overall Neurocognitive Composite Score44.3 T Scores
STANDARD_DEVIATION 6.4
45.6 T Scores
STANDARD_DEVIATION 4.8
44.95 T Scores
STANDARD_DEVIATION 5.6
Polysubstance Use Days in the Last 30 Days.42 Days
STANDARD_DEVIATION 1.41
.73 Days
STANDARD_DEVIATION 2.6
.57 Days
STANDARD_DEVIATION 2.05
Polysubstance Use Days in the Last 90 Days6.79 Days
STANDARD_DEVIATION 18.31
6.22 Days
STANDARD_DEVIATION 16.47
6.51 Days
STANDARD_DEVIATION 17.39
Premorbid IQ Estimate (WTAR)98.93 units on a scale
STANDARD_DEVIATION 13.3
100.28 units on a scale
STANDARD_DEVIATION 12.6
99.61 units on a scale
STANDARD_DEVIATION 12.95
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
9 Participants10 Participants19 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
18 Participants19 Participants37 Participants
Region of Enrollment
United States
30 Participants29 Participants59 Participants
Service Connected Disability (Yes)9 Participants7 Participants16 Participants
Sex: Female, Male
Female
1 Participants4 Participants5 Participants
Sex: Female, Male
Male
29 Participants25 Participants54 Participants
Social Security Disability Income (Yes)6 Participants10 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 30
other
Total, other adverse events
0 / 291 / 30
serious
Total, serious adverse events
0 / 290 / 30

Outcome results

Primary

Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer

Heavy alcohol use over 90 days as verified by Time Line Follow-back or breathalyzer findings. Minimum = 0. Maximum = 90. Fewer days is better.

Time frame: 3 months of active treatment

ArmMeasureValue (MEAN)Dispersion
CRT+IDCDays of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer5.49 DaysStandard Deviation 10.85
Computer Game Play+IDCDays of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer3.0 DaysStandard Deviation 5.89
p-value: <0.050.05% CI: [-8.23, 2.588]ANCOVA
Secondary

Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer

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.

Time frame: 30 days preceding 6 month follow-up, 3 months after active treatment.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
CRT+IDCDays of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer1.67 units on a scale (Number of Days)Standard Error 1.21
Computer Game Play+IDCDays of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer1.51 units on a scale (Number of Days)Standard Error 1.11
p-value: <0.050.05% CI: [-3.26, 3.61]ANCOVA
Secondary

Neurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)

Changes 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.

Time frame: Baseline to 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
CRT+IDCNeurocognitive 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
Computer Game Play+IDCNeurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)46.70 score on a scale (T scores)Standard Error 1.08
p-value: <0.0595% CI: [-1.61, 4.5]Mixed Models Analysis
Secondary

Penn Alcohol Craving Scale

Changes in self-ratings of alcohol craving from baseline to 6 months. Minimum score = 0. Maximum score = 30. Lower is better.

Time frame: 6 month follow-up

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
CRT+IDCPenn Alcohol Craving Scale3.94 score on a scaleStandard Error 1.45
Computer Game Play+IDCPenn Alcohol Craving Scale4.59 score on a scaleStandard Error 1.68
p-value: 0.770.05% CI: [1.45, 4.43]Mixed Models Analysis
Post Hoc

Clinical Global Index at 6 Months

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.

Time frame: 6 months after randomization

Population: Data was extracted from VA medical records and there were many participants who did not have sufficient information in their chart

ArmMeasureValue (MEAN)Dispersion
CRT+IDCClinical Global Index at 6 Months3.00 units on a scaleStandard Error 1.91
Computer Game Play+IDCClinical Global Index at 6 Months3.28 units on a scaleStandard Error 2.35
p-value: 0.050.05% CI: [0.19, 1.11]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026