- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609344
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Men
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72205
- UAMS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- male
- aged 18 or older
- resident of Arkansas
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SBIRT
Each intervention barbershop, will hold screening days, where a trained community health worker will be onsite to provide Screening, Brief Intervention, and Referral to Treatment (SBIRT).
|
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.
|
|
Other: Usual-care
Six months after completion of Time 1, barbershops in the usual-care arm will receive the intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Use - total number of drinking days
Time Frame: Baseline
|
At-risk drinking behavior measured as: number of drinking days |
Baseline
|
|
Alcohol Use - total number of drinking days
Time Frame: 3 months
|
At-risk drinking behavior measured as: number of drinking days |
3 months
|
|
Alcohol Use - total number of drinking days
Time Frame: 6 months
|
At-risk drinking behavior measured as: number of drinking days |
6 months
|
|
Alcohol Use - number of unhealthy drinking days
Time Frame: Baseline
|
At-risk drinking behavior measured as: number of unhealthy drinking days |
Baseline
|
|
Alcohol Use - number of unhealthy drinking days
Time Frame: 3 months
|
At-risk drinking behavior measured as: number of unhealthy drinking days |
3 months
|
|
Alcohol Use - total number of unhealthy drinking days
Time Frame: 6 months
|
At-risk drinking behavior measured as: number of unhealthy drinking days |
6 months
|
|
Mental Health - depression
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.
|
Baseline
|
|
Mental Health - depression
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.
|
3 months
|
|
Mental Health - depression
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.
|
6 months
|
|
Mental Health - Posttraumatic Stress Disorder (PTSD)
Time Frame: Baseline
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
|
Baseline
|
|
Mental Health - Posttraumatic Stress Disorder (PTSD)
Time Frame: 3 months
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
|
3 months
|
|
Mental Health - Posttraumatic Stress Disorder (PTSD)
Time Frame: 6 months
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
|
6 months
|
|
Social Support
Time Frame: Baseline
|
Family, friend, and partner support (number of people in support network)
|
Baseline
|
|
Social Support
Time Frame: 3 months
|
Family, friend, and partner support (number of people in support network)
|
3 months
|
|
Social Support
Time Frame: 6 months
|
Family, friend, and partner support (number of people in support network)
|
6 months
|
|
Healthcare Utilization
Time Frame: Baseline
|
Number of subjects who have utilized healthcare services
|
Baseline
|
|
Healthcare Utilization
Time Frame: 3 months
|
Number of subjects who have utilized healthcare services
|
3 months
|
|
Healthcare Utilization
Time Frame: 6 months
|
Number of subjects who have utilized healthcare services
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tiffany F Haynes, PhD, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 273439
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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