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

Primary Purpose

Alcohol Consumption, Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Step Away Chatbot
Step Away App
Sponsored by
University of Alaska Anchorage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring alcohol use disorder, alcohol consumption, primary prevention, smartphone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alaska Anchorage

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Step Away App

Step Away Chatbot

Step Away App Delay

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Alcohol Consumption (Drinks Per Day)
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
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)
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 (Percentage of Days Abstinent)
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.

Secondary Outcome Measures

Change in Readiness to Change
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. Scale ranges from -8 to 8; higher scores represent higher motivation to change.
Intervention Utilization Data
Intervention utilization data is used to calculate how frequently participants used the app or the chatbot during the study period. Means and standard deviations will be used to calculate this measure. Unit of measure is the number of times a user clicked on the app or the chabot during the study period.
Qualitative Perceptions of Step Away App and Chatbot
Retrospective qualitative interviews conducted with 10 chatbot and 10 app users to understand how they used technology and their recommendations for improving the experience. Semi-structured interviews were conducted with participants who had completed follow-up assessments. Participants were purposefully selected to maximize variation in the app (n=10) or the chatbot (n=10) usage. Eleven core interview questions were asked of both app and chatbot users, plus an additional chatbot user question about their experience with and impressions of the chatbot's conversational quality. A random number generator was used to select the 5 high users and 5 low users of each intervention. Qualitative analysis software was used to identify themes related to perceived helpfulness, barriers, motivators, and improvements; key themes related to these topics are reported here. No quantitative data were collected during the interviews.

Full Information

First Posted
June 22, 2020
Last Updated
November 1, 2022
Sponsor
University of Alaska Anchorage
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1. Study Identification

Unique Protocol Identification Number
NCT04447794
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alaska Anchorage

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Alcohol Use Disorder
Keywords
alcohol use disorder, alcohol consumption, primary prevention, smartphone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Step Away App
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.
Arm Title
Step Away Chatbot
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.
Arm Title
Step Away App Delay
Arm Type
No Intervention
Arm Description
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Intervention Type
Behavioral
Intervention Name(s)
Step Away Chatbot
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Step Away App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Alcohol Consumption (Drinks Per Day)
Description
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.
Time Frame
Baseline and 16 weeks
Title
Change in Alcohol-Related Problems
Description
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.
Time Frame
Baseline and 16 weeks
Title
Change in Alcohol Consumption (Heavy Drinking Days)
Description
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.
Time Frame
Baseline and 16 weeks
Title
Change in Alcohol Consumption (Percentage of Days Abstinent)
Description
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.
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Change in Readiness to Change
Description
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. Scale ranges from -8 to 8; higher scores represent higher motivation to change.
Time Frame
Baseline and 16 weeks
Title
Intervention Utilization Data
Description
Intervention utilization data is used to calculate how frequently participants used the app or the chatbot during the study period. Means and standard deviations will be used to calculate this measure. Unit of measure is the number of times a user clicked on the app or the chabot during the study period.
Time Frame
16 weeks
Title
Qualitative Perceptions of Step Away App and Chatbot
Description
Retrospective qualitative interviews conducted with 10 chatbot and 10 app users to understand how they used technology and their recommendations for improving the experience. Semi-structured interviews were conducted with participants who had completed follow-up assessments. Participants were purposefully selected to maximize variation in the app (n=10) or the chatbot (n=10) usage. Eleven core interview questions were asked of both app and chatbot users, plus an additional chatbot user question about their experience with and impressions of the chatbot's conversational quality. A random number generator was used to select the 5 high users and 5 low users of each intervention. Qualitative analysis software was used to identify themes related to perceived helpfulness, barriers, motivators, and improvements; key themes related to these topics are reported here. No quantitative data were collected during the interviews.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Dulin, PhD
Organizational Affiliation
University of Alaska Anchorage
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alaska Anchorage
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24821354
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.
Results Reference
background
PubMed Identifier
35576569
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.
Results Reference
derived

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

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