跳至主要内容
临床试验/NCT05609344
NCT05609344
进行中(未招募)
不适用

Barbershop Talk: Reducing Excessive Alcohol Consumption Among Men

University of Arkansas1 个研究点 分布在 1 个国家目标入组 611 人2023年6月26日

概览

阶段
不适用
干预措施
SBIRT
疾病 / 适应症
Drinking Behavior
发起方
University of Arkansas
入组人数
611
试验地点
1
主要终点
Alcohol Use - total number of drinking days
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2023年6月26日
结束日期
2027年7月31日
最后更新
上个月
研究类型
Interventional
研究设计
Crossover
性别
Male

研究者

责任方
Sponsor

入排标准

入选标准

  • aged 18 or older
  • resident of Arkansas

排除标准

  • 未提供

研究组 & 干预措施

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).

干预措施: SBIRT

Usual-care

Six months after completion of Time 1, barbershops in the usual-care arm will receive the intervention.

干预措施: SBIRT

结局指标

主要结局

Alcohol Use - total number of drinking days

时间窗: Baseline

At-risk drinking behavior measured as: number of drinking days

Alcohol Use - total number of drinking days

时间窗: 3 months

At-risk drinking behavior measured as: number of drinking days

Alcohol Use - number of unhealthy drinking days

时间窗: Baseline

At-risk drinking behavior measured as: number of unhealthy drinking days

Mental Health - depression

时间窗: 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.

Mental Health - depression

时间窗: 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.

Mental Health - Posttraumatic Stress Disorder (PTSD)

时间窗: Baseline

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)

Mental Health - Posttraumatic Stress Disorder (PTSD)

时间窗: 3 months

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)

Social Support

时间窗: Baseline

Family, friend, and partner support (number of people in support network)

Social Support

时间窗: 3 months

Family, friend, and partner support (number of people in support network)

Healthcare Utilization

时间窗: Baseline

Number of subjects who have utilized healthcare services

Healthcare Utilization

时间窗: 3 months

Number of subjects who have utilized healthcare services

Alcohol Use - number of unhealthy drinking days

时间窗: 3 months

At-risk drinking behavior measured as: number of unhealthy drinking days

Healthcare Utilization

时间窗: 6 months

Number of subjects who have utilized healthcare services

Alcohol Use - total number of drinking days

时间窗: 6 months

At-risk drinking behavior measured as: number of drinking days

Alcohol Use - total number of unhealthy drinking days

时间窗: 6 months

At-risk drinking behavior measured as: number of unhealthy drinking days

Mental Health - depression

时间窗: 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.

Mental Health - Posttraumatic Stress Disorder (PTSD)

时间窗: 6 months

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)

Social Support

时间窗: 6 months

Family, friend, and partner support (number of people in support network)

研究点 (1)

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