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临床试验/NCT06416059
NCT06416059招募中不适用

A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking

University of Houston2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Overall Anxiety Severity and Impairment Scale

研究概览

简要总结

The purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses 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 Black hazardous drinkers with clinical anxiety.

详细描述

Investigators will develop a culturally adapted, brief, single-session PFI delivered via a mobile health application for the Android and iOS platform through an iterative approach using expert input and semi-structured interview sessions. Next, Black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Black 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 Zoom; baseline and post-treatment data will be collected via Zoom 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

入选标准

  • Being 21 years of age or older
  • Self-identifying as Black or African American
  • Meeting criteria for current hazardous drinking pattern
  • Meeting criteria for clinical anxiety
  • Being able to provide written, informed consent
  • Owning a smartphone.

排除标准

  • Current participation in alcohol or other substance abuse treatment
  • Engaged in psychotherapy for anxiety or depression
  • Concurrent use of medication for anxiety or depression
  • Being pregnant by self-report
  • Residence outside of the United States confirmed via survey geolocation
  • Inability to provide a valid United States-issued driver's license or identification card to verify identity.

结局指标

主要结局

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). A higher score indicates a worse outcome.

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). A higher score indicates a worse outcome.

次要结局

  • Motivation to Reduce Alcohol Consumption Scale(Change from Baseline Pre PFI Completion to 3-months Post PFI Completion)
  • Modified Drinking Motives Questionnaire-Revised(Change from Baseline Pre PFI Completion to 3-months Post PFI Completion)
  • Alcohol Attitudes Scale(Change from Baseline Pre PFI Completion to 3-months Post PFI Completion)

研究者

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

Michael J. Zvolensky, Ph.D.

Distinguished Professor

University of Houston

研究点 (2)

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