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

NCT04447794 | Completed Results DMC

• 1 other identifier: 1521800-2
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Consumption; Alcohol Use Disorder

Keywords

alcohol use disorder; alcohol consumption; primary prevention; smartphone

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 16 weeks

• 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.

  Baseline and 16 weeks

• 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.

  Baseline and 16 weeks

• 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.

  Baseline and 16 weeks

Secondary Outcomes (3)

• Change in Readiness to Change

  Baseline and 16 weeks

• Intervention Utilization Data

  16 weeks

• Qualitative Perceptions of Step Away App and Chatbot

  16 weeks

Study Arms (3)

Step Away App

ACTIVE COMPARATOR

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

Behavioral: Step Away App

Step Away Chatbot

EXPERIMENTAL

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

Behavioral: Step Away Chatbot

Step Away App Delay

NO INTERVENTION

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

Interventions

Step Away Chatbot BEHAVIORAL

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 Chatbot

Step Away App BEHAVIORAL

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 App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alaska Anchorage: lead

Study Sites (1)

University of Alaska Anchorage

Anchorage, Alaska, 99508, United States

Location

Related Publications (3)

• 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.

  PMID: 24821354 BACKGROUND

• Sedotto RNM, Edwards AE, Dulin PL, King DK. Brief report: Aging adult utilization of an mHealth intervention for problem drinking. Front Public Health. 2024 Oct 28;12:1462737. doi: 10.3389/fpubh.2024.1462737. eCollection 2024.

  PMID: 39529711 DERIVED

• 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.

  PMID: 35576569 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Patrick Dulin
• Organization: University of Alaska Anchorage

pldulin@alaska.edu

(907) 786-1653

Study Officials

• Patrick Dulin, PhD

  University of Alaska Anchorage

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: June 2, 2020
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: September 1, 2023
• Results First Posted: September 1, 2023

Record last verified: 2022-11

Locations

US (1)