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临床试验/NCT02228967
NCT02228967已完成不适用

Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting

San Diego State University2 个研究点 分布在 1 个国家目标入组 791 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
791
试验地点
2
主要终点
Alcohol Use Disorders Identification Test (AUDIT) Total

研究概览

简要总结

An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be adapted for use in a large military hospital setting, and then pilot tested in a military emergency department (ED) to assess its potential for effectiveness and for further testing in a large-scale trial. SBIRT is an "opportunistic" approach whereby all adult patients in the ED are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.

The feasibility/formative research activities in the first phase (Phase I) of the study are not summative research, and therefore, do not lend themselves to testable hypotheses. Hypotheses with regard to the pilot randomized trial in Phase II are as follows:

  1. Participants in the SBIRT intervention will show relatively greater reductions over a six month period (or less increase) than the brochure/usual care control group in the prevalence of past-month heavy drinking, frequency of heavy drinking, past week number of drinks, and the AUDIT-based drinkers' index.
  2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy will show greater change in the SBIRT intervention group relative to the brochure/usual care control group.

In addition, exploratory analyses will examine the following: 3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.

详细描述

Deployment frequency and duration and combat exposure are implicated as risk factors for alcohol misuse and PTSD among military personnel. During the past 10 years, Department of Defense healthcare systems have observed steep increases in mental health and substance use services among personnel demobilizing from these conflicts. Although the alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach has shown promise as a low-cost, effective strategy for reducing alcohol use in civilians many of whom are risky drinkers but not yet dependent, it has not been adapted or tested in military health care settings for active duty personnel. This 2.5 year civilian-military collaborative study is highly responsive to exploring solutions to this emerging issue. The specific objectives for the overall project are given below.

Objective 1: Feasibility and Acceptability

  • Determine how the SBIRT intervention can be integrated into standard military emergency department (ED) operations by conducting record review and observation of the ED.
  • Develop and test the acceptability and usability (for both ED staff and potential participants) of the SBIRT approach by conducting focus groups with active duty personnel and garnering input from ED staff.
  • Develop an implementation/operations protocol for delivering SBIRT in the ED.

Objective 2: Adaptation

  • Apply a translational research approach to adapt SBIRT implementation in military settings and populations by using information from focus groups and input from ED staff.
  • Adapt the content of the SBIRT intervention to be relevant for military personnel, including language and images for counseling and materials using information from focus groups and input from ED staff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 or Older
  • Active Duty
  • Telephone Number for Follow-up
  • Healthy Enough to Participate
  • Positive Screen for Risky Drinking

排除标准

  • Non-Military
  • Low Level Drinking

结局指标

主要结局

Alcohol Use Disorders Identification Test (AUDIT) Total

时间窗: Baseline, Follow-up (Up to 7 months)

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

次要结局

  • Readiness to Change Scale(Baseline, Follow-up (Up to 7 months))
  • AUDIT-C or Drinkers Index(Baseline, Follow-up (Up to 7 months))
  • Controlled Drinking Self-Efficacy Scale (CDSES)(Baseline, Follow-up (Up to 7 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Reed, PhD

Director

San Diego State University

研究点 (2)

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