UAMS
Little Rock, Arkansas, 72205, United States
NCT Number: NCT05609344
Unhealthy drinking is considered one of the top 10 public health concerns in the United States. Not only has heavy drinking been linked to poorer overall health and the chances of getting cancer and cardiovascular diseases, but it also causes about 88,000 deaths and 2.5 million years of potential life lost each year in the U.S. Men living in rural areas tend to drink more. In Arkansas, a rural state with high rates of unhealthy drinking, men are more likely to report heavy drinking (4 or more drinks a day) and to drink more when binge drinking. Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based, multilevel, integrated public health approach for early intervention and timely referral to more intensive treatment for those with substance use disorders. SBIRTs have been successfully used in primary care and emergency settings.
However, men in rural areas may lack access to evidence-based care for unhealthy drinking due to many factors, including limited healthcare providers and insurance standing. Given the increased chances of death and illness linked to harmful drinking among rural men and the serious health consequences involved, it is urgent to improve access to evidence-based care. This can be achieved by expanding services into community settings that men in rural areas are more likely to visit, such as barbershops. Thus, the goals of this proposed Hybrid Type 2 pragmatic effectiveness-implementation trial are to: 1) test the effectiveness of an evidence-based SBIRT intervention for use within barbershops (Barbershop Talk); and 2) generate the scientific evidence needed to implement SBIRTs in "real world" settings. Data from this study will further our understanding of how to reduce the chances of experiencing alcohol attributable morbidity and mortality among men living in rural areas. Data will also enhance our understanding of strategies that can improve the implementation of evidence-based care models in non-clinical settings, thereby extending the reach of evidence-based care to rural communities with high needs.
This study is active but is not currently recruiting participants.
18 year and older
Male
Interventional
Not applicable
Little Rock, Arkansas, 72205, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low risk individuals will receive an educational pamphlet about alcohol use and the impact on health. Moderate Risk individuals will receive a brief alcohol intervention. High risk individuals will receive the brief alcohol intervention and be referred to specialty treatment.
Time frame: Baseline
At-risk drinking behavior measured as:
number of drinking days
Time frame: 3 months
At-risk drinking behavior measured as:
number of drinking days
Time frame: 6 months
At-risk drinking behavior measured as:
number of drinking days
Time frame: Baseline
At-risk drinking behavior measured as:
number of unhealthy drinking days
Time frame: 3 months
At-risk drinking behavior measured as:
number of unhealthy drinking days
Time frame: 6 months
At-risk drinking behavior measured as:
number of unhealthy drinking days
Time frame: Baseline
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Time frame: 3 months
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Time frame: 6 months
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Time frame: Baseline
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time frame: 3 months
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time frame: 6 months
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time frame: Baseline
Family, friend, and partner support (number of people in support network)
Time frame: 3 months
Family, friend, and partner support (number of people in support network)
Time frame: 6 months
Family, friend, and partner support (number of people in support network)
Time frame: Baseline
Number of subjects who have utilized healthcare services
Time frame: 3 months
Number of subjects who have utilized healthcare services
Time frame: 6 months
Number of subjects who have utilized healthcare services
University of Arkansas
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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