- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447794
Step Away: Comparing a Chatbot-delivered Alcohol Intervention With a Smartphone App
Can a Chatbot-delivered Alcohol Intervention Engage Users and Enhance Outcomes Over a Smartphone App? Development and Feasibility Testing of a StepAway 'Bot'
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alaska
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Anchorage, Alaska, United States, 99508
- University of Alaska Anchorage
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alcohol Consumption (Drinks Per Day)
Time Frame: 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.
|
Baseline and 16 weeks
|
Change in Alcohol-Related Problems
Time Frame: 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.
|
Baseline and 16 weeks
|
Change in Alcohol Consumption (Heavy Drinking Days)
Time Frame: 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.
|
Baseline and 16 weeks
|
Change in Alcohol Consumption (Percentage of Days Abstinent)
Time Frame: 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.
|
Baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Readiness to Change
Time Frame: 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.
Scale ranges from -8 to 8; higher scores represent higher motivation to change.
|
Baseline and 16 weeks
|
Intervention Utilization Data
Time Frame: 16 weeks
|
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.
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16 weeks
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Qualitative Perceptions of Step Away App and Chatbot
Time Frame: 16 weeks
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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.
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16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Dulin, PhD, University of Alaska Anchorage
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1521800-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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