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This research study will examine the effectiveness of a brief, computerized motivational intervention plus treatment-as-usual to treatment-as-usual alone for treating alcohol misuse in Veterans presenting to primary care. The investigators aim to recruit 162 Veterans screening positive on the AUDIT-C to participate in this study. Participants will be randomly assigned to one of the two intervention conditions and be asked to complete a baseline assessment and two follow-up assessments conducted at three and six months post treatment. Baseline assessments will be conducted in person by a trained research assistant, while all follow-up interviews will be conducted over the phone. The primary outcome for this clinical trial is the reduction in the number of heavy drinking days. Several secondary outcomes will be collected including health status, depressive symptoms, consequences of drinking, pain symptoms, and distress tolerance. The findings from this study may have large scale implications for how alcohol misuse is treated in primary care. In addition, this study will provide evidence for the feasibility of using the computer as a method for delivering evidence-based mental health interventions in primary care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care only | Active Comparator | standard care only - harmful effects of alcohol use and NIAAA limits |
|
| Brief alcohol intervention | Experimental | Group receiving brief alcohol intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brief alcohol intervention | Behavioral | this intervention consists of brief assessment and feedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Percentage of Heavy Drinking Days | reduction in the percentage of heavy drinking days over the prior 30-days. a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men). | baseline to six-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Cucciare, PhD | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | No. Little Rock | Arkansas | 72114-1706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22388536 | Result | Cucciare MA, Ghaus S. A Web-based intervention for alcohol misuse in VA primary care. Psychiatr Serv. 2012 Mar;63(3):292. doi: 10.1176/appi.ps.20120p292. No abstract available. | |
| 23218847 | Result | Cucciare MA, Boden MT, Weingardt KR. Brief alcohol counseling improves mental health functioning in veterans with alcohol misuse: results from a randomized trial. J Affect Disord. 2013 May;147(1-3):312-7. doi: 10.1016/j.jad.2012.11.028. Epub 2012 Dec 6. |
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This project will include data from 167 Veterans screening positive for alcohol misuse (without and without posttraumatic stress disorder [PTSD] or depression). Data was collected at three time points including baseline, 3- and 6-month follow-up. The final dataset includes quantitative data including on alcohol consumption, and symptoms of PTSD, and depression. The final dataset will be stripped of identifiers prior to sharing. Release of data for data sharing will occur after publication of the main findings from the dataset. The investigators will make the data and associated documentation available to users under our own auspices by mailing an encrypted hard-drive to users. A data-sharing agreement must be signed that accounts for (1) commitment to using the data only for research; (2) IRB approval at the host institution, (3) a plan for securing the data using appropriate technology, and (4) an agreed upon plan to destroy or return the data upon completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Group receiving treatment-as-usual. Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System. |
| FG001 | Arm 2 | Group receiving treatment-as-usual plus a brief alcohol intervention brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component. Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Group receiving treatment-as-usual. Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System. |
| BG001 | Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Reduction in Percentage of Heavy Drinking Days | reduction in the percentage of heavy drinking days over the prior 30-days. a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men). | Posted | Mean | Standard Deviation | percentage of heavy drinking days | baseline to six-month follow-up |
|
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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 | Arm 1 | Group receiving treatment-as-usual. Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael A. Cucciare, Ph.D. | Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Healthcare System | 501-257-1068 | michael.cucciare@va.gov |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
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| standard care | Behavioral | education about harmful effects of alcohol use and NIAAA recommended drinking limits |
|
| 23490572 | Result | Cucciare MA, Weingardt KR, Ghaus S, Boden MT, Frayne SM. A randomized controlled trial of a web-delivered brief alcohol intervention in Veterans Affairs primary care. J Stud Alcohol Drugs. 2013 May;74(3):428-36. doi: 10.15288/jsad.2013.74.428. |
Group receiving treatment-as-usual plus a brief alcohol intervention
brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm 2 | Group receiving treatment-as-usual plus a brief alcohol intervention brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component. Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System. | 0 | 0 | 0 | 0 |
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| D011787 |
| Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |