Step Away: Comparing a Chatbot-delivered Alcohol Intervention With a Smartphone App

Sponsor
University of Alaska Anchorage (Other)
Overall Status
Completed
CT.gov ID
NCT04447794
Collaborator
(none)
191
1
3
7.2
26.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Step Away Chatbot
  • Behavioral: Step Away App
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
191 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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'
Actual Study Start Date :
Jun 2, 2020
Actual Primary Completion Date :
Jan 6, 2021
Actual Study Completion Date :
Jan 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Step Away App

Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.

Behavioral: Step Away App
The Step Away app is a smartphone-based mobile intervention system. It is informed by three theoretical constructs that are considered the most important "active ingredients" for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.

Experimental: Step Away Chatbot

Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.

Behavioral: Step Away Chatbot
The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text. The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.

No Intervention: Step Away App Delay

Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.

Outcome Measures

Primary Outcome Measures

  1. Change in alcohol consumption [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 90-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.

  2. Alcohol-related problems [Baseline and 16 weeks]

    The Drinkers' Inventory of Consequences (DrInC) is a 50-item measure that assesses consequences of drinking across five domains: physical, intrapersonal, social responsibility, interpersonal, and impulse control. In this study, participants will rate their frequency of experiencing each problem in the past 3 months from 0 (never/not at all) to 3 (almost daily/very much) at the baseline and at the 4 month follow up assessment. The DrInC has high test-retest reliability and internal consistency, and has been found to have convergent, divergent, and discriminant validity among alcohol treatment seekers. The DrInC will be administered at baseline and follow-up to examine between-group changes over time.

Secondary Outcome Measures

  1. Readiness to change [Baseline and 16 weeks]

    Given that the main underlying theoretical framework of Step Away is motivational enhancement (ME), we want to examine readiness to change as a mediating variable. We will utilize the Readiness to Change Treatment Version (RCQTV) in this study to assess this construct. The RCQTV has been shown to have solid reliability and validity and has been modified for individuals contemplating or engaged in treatment for alcohol problems.

  2. Intervention utilization data [16 weeks]

    Data will be used to calculate the number of unique users per week, number of unique active users per week. We will calculate the number of times each module in both interventions are viewed and completed, as well as the number of times in-the-moment-tools are accessed, and the number of daily questionnaires completed by each participant using either intervention. Means (standard deviations) and confidence intervals (CI) and medians (interquartile ranges) will be used to calculate these measures. We will also review interactions between chatbot users and the chatbot by viewing chat histories and where a user ended a conversation.

  3. Perceptions of Step Away app and chatbot [16 weeks]

    Retrospective qualitative interviews will be conducted with 10 chat and app users to understand their use, and perceived helpfulness, of various features, barriers, motivators, and their recommendations for improving the experience.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 USAUDIT66

  • unwilling or unable to complete follow-up assessment

  • non-U.S. residency

  • unable to read or text in English

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alaska Anchorage Anchorage Alaska United States 99508

Sponsors and Collaborators

  • University of Alaska Anchorage

Investigators

  • Principal Investigator: Patrick Dulin, PhD, University of Alaska Anchorage

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
University of Alaska Anchorage
ClinicalTrials.gov Identifier:
NCT04447794
Other Study ID Numbers:
  • 1521800-2
First Posted:
Jun 25, 2020
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Alaska Anchorage
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021