Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Motivation to Reduce Alcohol Consumption Scale
研究概览
简要总结
The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with anxiety.
详细描述
In the first phase, the investigators will collect qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility of a novel, brief, integrated, culturally adapted computer-based personalized feedback intervention (PFI). In the second phase, Latinx hazardous drinkers with clinical anxiety will be recruited and randomly assigned to either the refined culturally adapted anxiety-alcohol PFI (AA-PFI 2.0) or a control PFI (C-PFI). Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-, 3-, and 6-month follow-up data will be collected online remotely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the age of 21 to 75 years of age
- •Being self-identified as Latinx or Hispanic
- •Fluent in Spanish
- •Meeting criteria for current hazardous drinking pattern
- •Meeting criteria for clinical anxiety
- •Being able to provide written, informed consent
排除标准
- •Being involved in alcohol or other substance use program
- •Currently pregnant
- •Current engagement in psychotherapy for anxiety
结局指标
主要结局
Motivation to Reduce Alcohol Consumption Scale
时间窗: Change from Baseline Pre PFI completion to Baseline Post PFI completion
The 1-item Motivation to Reduce Alcohol Consumption Scale will be used to measure current motivation/intention to reduce alcohol. Participants will be asked to select the statement that best describes their motivation/intention to reduce drinking (e.g., "I really want to cut down on drinking alcohol and intend to in the next month"). Higher scores on this measure indicate greater motivation/intention to reduce alcohol consumption (possible range (0-7).
Modified Drinking Motives Questionnaire-Revised
时间窗: Change from Baseline Pre PFI completion to Baseline Post PFI completion
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 4-item "Coping-anxiety" subscale will be used as a measure of expectancies of drinking to reduce/cope with anxiety. The measure utilizes a 5-point Likert scale ranging from 1 (almost never/never) to 5 (almost always/always). Scores are averaged with higher scores indicating greater expectancies of drinking to reduce/cope with anxiety (possible range 1 to 5).
Alcohol Attitudes Scale
时间窗: Change from Baseline Pre PFI completion to Baseline Post PFI completion
The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good"). Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Scores will be averaged to create a composite score (possible range 1 to 7). Higher scores indicate greater maladaptive attitudes for drinking.
次要结局
- Alcohol Use Disorders Identification Test(Change from Baseline Pre PFI Completion to 6-months Post PFI Completion)
- Overall Anxiety Severity and Impairment Scale(Change from Baseline Pre PFI Completion to 6-months Post PFI Completion)
研究者
Michael J. Zvolensky, Ph.D.
Distinguished Professor
University of Houston