Alcohol Consumption
Conditions
Keywords
Alcohol Consumption
Brief summary
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.
Interventions
BEHAVIORALbrief alcohol intervention
this intervention consists of brief assessment and feedback
BEHAVIORALstandard care
education about harmful effects of alcohol use and NIAAA recommended drinking limits
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years of age, * speak and read English, * U.S. Veteran status, * screen positive on the AUDIT-C
Exclusion criteria
* the presence of any cognitive difficulties that interfere with one's ability to consent to study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Percentage of Heavy Drinking Days | baseline to six-month follow-up | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| 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. | 89 |
| Total | 167 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 15.9 | 60.8 years STANDARD_DEVIATION 14.1 | 59.0 years STANDARD_DEVIATION 15 |
| Gender Female | 10 Participants | 10 Participants | 20 Participants |
| Gender Male | 68 Participants | 79 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: baseline to six-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Reduction in Percentage of Heavy Drinking Days | 14.0 percentage of heavy drinking days | Standard Deviation 25 |
| Arm 2 | Reduction in Percentage of Heavy Drinking Days | 11.0 percentage of heavy drinking days | Standard Deviation 23 |