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临床试验/NCT05288699
NCT05288699招募中不适用

Brief Personalized Feedback Intervention for Latinx Hazardous Drinkers: A Community-Based Intervention

Michael J. Zvolensky, Ph.D.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Alcohol Use Disorders Identification Test

研究概览

简要总结

The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android platform, optimized to deliver a 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 clinical anxiety.

详细描述

Investigators will develop a culturally adapted, brief, single-session, Spanish language, PFI delivered via a mobile health application for the Android platform through an iterative approach using expert input and focus groups. Next, Latinx hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Latinx hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •21 years of age or older
  • •self-identified as Latinx or Hispanic
  • •fluent in Spanish
  • •current hazardous drinking pattern
  • •current clinical anxiety
  • •able to provide written, informed consent
  • •owning an Android smartphone

排除标准

  • •currently involved in alcohol or other substance use program
  • •concurrent use of medication for anxiety or depression
  • •current engagement in psychotherapy for anxiety or depression

研究组 & 干预措施

Aliento

Experimental

Participants complete the brief (~30 minute) intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application.

干预措施: Aliento (Behavioral)

结局指标

主要结局

Alcohol Use Disorders Identification Test

时间窗: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

The Alcohol Use Disorders Identification Test will be used to assess drinking quantity, craving, and related consequences to alcohol use. The 10 items are rated with various Likert-type scales. The measure produces a total score by adding all of the items of the measure with higher scores indicating greater problems with alcohol (possible range 0 to 40).

Overall Anxiety Severity and Impairment Scale

时间窗: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

The 5-item Overall Anxiety Severity and Impairment Scale will be used to assess anxiety symptom severity and impairment. Each of the items is rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score (possible range 0 to 20).

次要结局

  • Alcohol Attitudes Scale(Change from Baseline Pre PFI completion to Baseline Post PFI completion)
  • Modified Drinking Motives Questionnaire-Revised(Change from Baseline Pre PFI completion to Baseline Post PFI completion)
  • Motivation to Reduce Alcohol Consumption Scale(Change from Baseline Pre PFI completion to Baseline Post PFI completion)

研究者

发起方
Michael J. Zvolensky, Ph.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael J. Zvolensky, Ph.D.

Distinguished Professor

University of Houston

研究点 (1)

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