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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT+IDC | Experimental | Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling |
|
| Computer Game Play+IDC | Active Comparator | Computer arcade games for 13 weeks plus Individual Drug Counseling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Remediation Training | Behavioral | Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months of active treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days preceding 6 month follow-up, 3 months after active treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morris D. Bell, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 13 Week |
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| 26 Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Computer Game Play+IDC |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Days | 3 months of active treatment |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admitted to emergency department for severe alcohol intoxication | Psychiatric disorders | Systematic Assessment | This is a common occurrence in the AUD population and was unrelated to the intervention. |
Due to the pandemic, recruitment was below the 90 subjects proposed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Morris Bell, Ph.D., Senior Research Career Scientist | VA Connecticut Healthcare System | 203-932-5711 | 2281 | morris.bell@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2018 | Oct 19, 2022 | Prot_SAP_000.pdf |
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| 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. |
| 6 month follow-up |
| 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. | Baseline to 6 months |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Lifetime Months of Alcohol Use | Minimum value = 1 month, Maximum value = 1080 months More months of heavy drinking is worse | Mean | Standard Deviation | Months |
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| Alcohol Use Days in Last 30 Days | Minimum value is 0 days, Maximum value is 30 days Fewer days is better. | Mean | Standard Deviation | Days |
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| Alcohol Use Days in Last 90 Days | Minimum value is 0 days, Maximum value is 90 days Fewer days is better. | Mean | Standard Deviation | Days |
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| Polysubstance Use Days in the Last 30 Days | Minimum value is 0 days, Maximum value is 30 days Fewer days is better. | Mean | Standard Deviation | Days |
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| Polysubstance Use Days in the Last 90 Days | Minimum value is 0 days, Maximum value is 90 days Fewer days is better. | Mean | Standard Deviation | Days |
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| Service Connected Disability (Yes) | Count of Participants | Participants |
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| Social Security Disability Income (Yes) | Count of Participants | Participants |
|
| Education (years) | Mean | Standard Deviation | years |
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| Premorbid IQ Estimate (WTAR) | Minimum score = 60. Maximum = 140 Higher is better | Mean | Standard Deviation | units on a scale |
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| Overall Neurocognitive Composite Score | 50 indicates the population mean with a standard deviation of 10; Minimum T Score = 30. Maximum = 80; Higher is better | Mean | Standard Deviation | T Scores |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale (Number of Days) | 30 days preceding 6 month follow-up, 3 months after active treatment. |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 month follow-up |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale (T scores) | Baseline to 6 months |
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| 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. | Data was extracted from VA medical records and there were many participants who did not have sufficient information in their chart | Posted | Mean | Standard Error | units on a scale | 6 months after randomization |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 1 | 30 |
|
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