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.
COMPLETED
NA
191 participants
Baseline and 16 weeks
2023-09-01
Participant Flow
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
| 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
| 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 weeksPopulation: 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
| 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 weeksThe 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
| 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 weeksThe 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
| 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 weeksThe 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
| 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 weeksGiven 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
| 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 weeksPopulation: 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
| 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 weeksPopulation: 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
| 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
Step Away Chatbot
Step Away App Delay
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place