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临床试验/NCT04447794
NCT04447794已完成不适用

Can a Chatbot-delivered Alcohol Intervention Engage Users and Enhance Outcomes Over a Smartphone App? Development and Feasibility Testing of a StepAway 'Bot'

University of Alaska Anchorage2 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2020年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
191
试验地点
2
主要终点
Change in Alcohol Consumption (Percentage of Days Abstinent)

研究概览

简要总结

A wide gap exists between the number of people needing alcohol treatment and those actually receiving it. This study builds on a previous one that indicated that smartphone-based intervention can help increase the number of people who receive alcohol intervention services and decrease treatment barriers. Improvements to the previously developed app, Step Away, will be made. In addition, a new method of delivering the Step Away intervention via an online, interactive chatbot, will be developed with the goal of improving engagement and effectiveness. Participants will be recruited and outcomes between the two interventions examined to determine if the Step Away chatbot has enhanced user engagement, intervention fidelity and outcome efficacy in comparison to the Step Away app amongst a group of problem drinkers. Participants will also be interviewed to determine their perceptions of both interventions with a view towards understanding barriers to user engagement.

详细描述

A wide gap exists between the number of individuals needing alcohol treatment and those actually receiving it. Technologically-delivered interventions may dramatically increase the number of individuals who receive needed alcohol intervention services due to their ability to circumvent treatment barriers. Smartphones are the ideal devices to provide empirically-supported intervention assistance whenever and wherever it is needed. Our research team previously developed and tested a stand-alone, self-administered smartphone-based intervention system for alcohol use disorders that was based on empirically supported face-to-face treatments (the Location-Based Monitoring and Intervention for Alcohol Use Disorders (LBMI-A) system). A revised and improved iPhone-based version, Step Away, was developed. Step Away usage data indicate that user engagement with modules that are not "pushed" to the user is relatively low, which is a problem that many health apps experience. A new method of delivering Step Away through an artificially intelligent (AI) chatbot will be developed that holds potential for providing enhanced user engagement and effectiveness as it can reach out through a text interface to introduce new intervention steps and respond to the user with Step Away's in-the-moment help with having a craving, experiencing distress or needing social support. The first phase of this study will focus on developing a Step Away chatbot and enhance the existing Step Away app's user interface. The second phase will entail a pilot study to determine if the Step Away chatbot has enhanced user engagement, intervention fidelity and outcome efficacy in comparison to the Step Away app amongst a group of problem drinkers. Participants will be interviewed to determine their perceptions of both interventions with a view towards understanding barriers to user engagement. Finally, this project will set the stage for a further, large-scale evaluation of Step Away, the content of which will be determined by the outcome of the pilot study.

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
None

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

  • being 18 years of age or older
  • being a problem drinker, i.e., having a score of 8 or higher for men and 6 or higher for women on the United States Alcohol Use Disorders Identification Test (USAUDIT)
  • drinking 5 or more (for men ages 18-65), or 4 or more (for women and men over age 65), standard drinks on at least one occasion during the last 90 day
  • owning either an iPhone or Android smartphone with an accompanying cellular and data plan
  • U.S. residency
  • able to read and text in English

排除标准

  • being more than 30 days abstinent at baseline
  • being in alcohol or drug abuse treatment currently
  • being pregnant or nursing
  • having a moderate to severe level of alcohol use disorder, i.e., having a score of 20 or higher on the USAUDIT
  • unwilling or unable to complete follow-up assessment
  • non-U.S. residency
  • unable to read or text in English

结局指标

主要结局

Change in Alcohol Consumption (Percentage of Days Abstinent)

时间窗: Baseline and 16 weeks

The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.

Change in Alcohol Consumption (Drinks Per Day)

时间窗: Baseline and 16 weeks

The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.

Change in Alcohol-Related Problems

时间窗: Baseline and 16 weeks

The Short Inventory of Problems - Revised (SIP-R) is a self-report inventory of adverse consequences associated with drug and alcohol use. It is comprised of 17 questions scored on a 4-point Likert scale from 1 (never) to 4 (daily or almost daily). Item responses are summed to produce a total score and five subscale scores (physical, intrapersonal, social responsibility, interpersonal, and impulse control). Higher scores indicate more life problems related to alcohol use. In populations of problem drinkers, the SIP-R has demonstrated good concurrent validity and internal consistency. The SIP-R will be administered at baseline and follow-up to examine between group changes over time. Scale ranges from 17 to 68.

Change in Alcohol Consumption (Heavy Drinking Days)

时间窗: Baseline and 16 weeks

The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.

次要结局

  • Change in Readiness to Change(Baseline and 16 weeks)
  • Qualitative Perceptions of Step Away App and Chatbot(16 weeks)
  • Intervention Utilization Data(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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