Trial Outcomes & Findings for Step Away: Comparing a Chatbot-delivered Alcohol Intervention With a Smartphone App (NCT NCT04447794)

NCT ID: NCT04447794

Last Updated: 2023-09-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

191 participants

Primary outcome timeframe

Baseline and 16 weeks

Results posted on

2023-09-01

Participant Flow

Participant milestones

Participant milestones
Measure
Step Away App
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
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.
Overall Study
STARTED
64
64
63
Overall Study
COMPLETED
61
60
55
Overall Study
NOT COMPLETED
3
4
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Step Away App
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
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.
Overall Study
Lost to Follow-up
2
3
8
Overall Study
Withdrawal by Subject
1
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Step Away App
n=64 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=64 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away App Delay
n=63 Participants
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Total
n=191 Participants
Total of all reporting groups
Age, Continuous
41.64 years
STANDARD_DEVIATION 13.13 • n=99 Participants
39.55 years
STANDARD_DEVIATION 12.30 • n=107 Participants
39.68 years
STANDARD_DEVIATION 12.46 • n=206 Participants
40.29 years
STANDARD_DEVIATION 12.61 • n=7 Participants
Sex: Female, Male
Female
34 Participants
n=99 Participants
32 Participants
n=107 Participants
37 Participants
n=206 Participants
103 Participants
n=7 Participants
Sex: Female, Male
Male
30 Participants
n=99 Participants
32 Participants
n=107 Participants
26 Participants
n=206 Participants
88 Participants
n=7 Participants
Race/Ethnicity, Customized
Black or African American
8 Participants
n=99 Participants
9 Participants
n=107 Participants
9 Participants
n=206 Participants
26 Participants
n=7 Participants
Race/Ethnicity, Customized
Causasian
50 Participants
n=99 Participants
42 Participants
n=107 Participants
45 Participants
n=206 Participants
137 Participants
n=7 Participants
Race/Ethnicity, Customized
Asian American
2 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
12 Participants
n=7 Participants
Race/Ethnicity, Customized
Alaska Native or American Indian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
3 Participants
n=7 Participants
Race/Ethnicity, Customized
Hispanic or Latinx
3 Participants
n=99 Participants
8 Participants
n=107 Participants
0 Participants
n=206 Participants
11 Participants
n=7 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
2 Participants
n=7 Participants
Region of Enrollment
United States
64 Participants
n=99 Participants
64 Participants
n=107 Participants
63 Participants
n=206 Participants
191 Participants
n=7 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Population: Of the 150 participants analyzed, only 114 provided TLFB data.

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.

Outcome measures

Outcome measures
Measure
Step Away App
n=42 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=39 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
n=33 Participants
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Change in Alcohol Consumption (Drinks Per Day)
-1.18 drinks per day
Standard Deviation 1.48
-0.90 drinks per day
Standard Deviation 0.96
-0.63 drinks per day
Standard Deviation 1.33

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Step Away App
n=55 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=50 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
n=45 Participants
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Change in Alcohol-Related Problems
-3.53 score on a scale
Standard Deviation 5.54
-2.82 score on a scale
Standard Deviation 11.39
-3.98 score on a scale
Standard Deviation 7.47

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Step Away App
n=42 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=39 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
n=33 Participants
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Change in Alcohol Consumption (Heavy Drinking Days)
-4.40 heavy drinking days
Standard Deviation 7.28
-3.95 heavy drinking days
Standard Deviation 5.70
-1.36 heavy drinking days
Standard Deviation 6.26

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Step Away App
n=42 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=39 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
n=33 Participants
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Change in Alcohol Consumption (Percentage of Days Abstinent)
19.60 percentage of days abstinent
Standard Deviation 28.97
14.02 percentage of days abstinent
Standard Deviation 22.05
17.37 percentage of days abstinent
Standard Deviation 32.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Step Away App
n=55 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=50 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
n=45 Participants
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Change in Readiness to Change
0.05 score on a scale
Standard Deviation 0.76
0.48 score on a scale
Standard Deviation 0.74
0.00 score on a scale
Standard Deviation 0.85

SECONDARY outcome

Timeframe: 16 weeks

Population: Delay group did not have access to either intervention during the study period.

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.

Outcome measures

Outcome measures
Measure
Step Away App
n=55 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=32 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Intervention Utilization Data
33.96 User clicks
Standard Deviation 38.16
24.56 User clicks
Standard Deviation 28.68

SECONDARY outcome

Timeframe: 16 weeks

Population: This outcome measure explored the perceptions and experiences of the users of the app and the chatbot The delay group were not provided access to either the app or the chatbot during the intervention period so they were not included in the analysis.

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.

Outcome measures

Outcome measures
Measure
Step Away App
n=10 Participants
Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment. 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.
Step Away Chatbot
n=10 Participants
Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment. 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.
Step Away Delay
Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
Qualitative Perceptions of Step Away App and Chatbot
Overall Experience as User
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Things Users Learned from Use
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Mini-Modules
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Prompts for Use
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Ability to Anticipate Triggers
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Conversation Quality
0 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Personalization to User
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Thing That Support Sustainability of Use
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Things That Prevent Sustainability of Use
1 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Human Contact Encouraging Use
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Impact of Pandemic on Use
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Recommended Changes
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Other Thoughts on Experience
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Things Helpful
9 Participants
0 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Things Not Helpful
4 Participants
7 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Facebook Platform
0 Participants
3 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Lack of Self-Direction
0 Participants
7 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Notifications
7 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Lack of Prompts
0 Participants
3 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention Related to Repetitive
4 Participants
7 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention Related to Set Up
6 Participants
1 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Technology Glitch
10 Participants
10 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Unhelpful Tips or Strategies
2 Participants
2 Participants
Qualitative Perceptions of Step Away App and Chatbot
Any Mention of Usability
5 Participants
9 Participants

Adverse Events

Step Away App

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Step Away Chatbot

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Step Away App Delay

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patrick Dulin

University of Alaska Anchorage

Phone: (907) 786-1653

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place