Clinical trial NCT04447794: Step Away: Comparing a Chatbot-delivered Alcohol Intervention With a Smartphone App
Official title: Can a Chatbot-delivered Alcohol Intervention Engage Users and Enhance Outcomes Over a Smartphone App? Development and Feasibility Testing of a StepAway 'Bot'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Alcohol Use Disorder
Keywords: alcohol use disorder
alcohol consumption
primary prevention
smartphone
Lead sponsor: University of Alaska Anchorage
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Alcohol Consumption (Drinks Per Day)
timeFrame: Baseline and 16 weeks
measure: Change in Alcohol-Related Problems
timeFrame: Baseline and 16 weeks
measure: Change in Alcohol Consumption (Heavy Drinking Days)
timeFrame: Baseline and 16 weeks
measure: Change in Alcohol Consumption (Percentage of Days Abstinent)
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change in Readiness to Change
timeFrame: Baseline and 16 weeks
measure: Intervention Utilization Data
timeFrame: 16 weeks
measure: Qualitative Perceptions of Step Away App and Chatbot
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: University of Alaska Anchorage
state: Alaska
Study officials:
affiliation: University of Alaska Anchorage
name: Patrick Dulin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dulin PL, Gonzalez VM, Campbell K. Results of a pilot test of a self-administered smartphone-based treatment system for alcohol use disorders: usability and early outcomes. Subst Abus. 2014;35(2):168-75. doi: 10.1080/08897077.2013.821437.
citation: Dulin P, Mertz R, Edwards A, King D. Contrasting a Mobile App With a Conversational Chatbot for Reducing Alcohol Consumption: Randomized Controlled Pilot Trial. JMIR Form Res. 2022 May 16;6(5):e33037. doi: 10.2196/33037.