VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516, United States
NCT Number: NCT02664038
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
West Haven, Connecticut, 06516, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
Time frame: 3 months of active treatment
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: 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.
Time frame: 6 month follow-up
Changes in self-ratings of alcohol craving from baseline to 6 months. Minimum score = 0. Maximum score = 30. Lower is better.
Time frame: Baseline to 6 months
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.
VA Office of Research and Development
Fed
Cognitive Training in the Treatment of Alcohol Use Disorders in Older Veterans
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