Mobile App Intervention for Risky Alcohol Use

(TRAC-ER Trial)

Recruiting at 1 trial location

Overseen By Carolyn Lauckner, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Kentucky

Disqualifiers: Active psychosis, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

405 Participants Needed

Trial Summary

What is the purpose of this trial?

Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to reduce risky alcohol use, so it might not require changes to your medication.

What data supports the effectiveness of the treatment TRAC-ER for risky alcohol use?

Research shows that smartphone apps can help reduce alcohol consumption by increasing users' awareness of their drinking habits and providing personalized feedback and goal-setting features. These elements have been found to encourage users to decrease their alcohol use. ^{1 2 3 4 5}

Is the mobile app intervention for risky alcohol use safe for humans?

The available research on smartphone apps for managing alcohol use, including those like Step Away and LBMI-A, suggests they are generally safe and well-received by users. Participants found these apps easy to use and helpful in increasing awareness of their alcohol consumption, with no significant safety concerns reported. ^{1 2 3 4 6}

How is the TRAC-ER treatment for risky alcohol use different from other treatments?

TRAC-ER is unique because it is a smartphone-based app that provides a self-administered intervention for alcohol use, allowing users to access support anytime and anywhere. Unlike traditional treatments that require in-person visits, this app offers immediate, personalized feedback and tools to help reduce alcohol consumption, making it more accessible and convenient for users. ^{1 4 5 7 8}

Research Team

Carolyn Lauckner, PhD

Principal Investigator

University of Kentucky

Trace Kershaw, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for sexual minority males and transgender individuals aged 18-35 who drink alcohol at risky levels, own a smartphone, are HIV-negative, meet CDC PrEP criteria, and identify as non-heterosexual. It's not for those who don't speak English, have severe alcohol withdrawal symptoms or mental illness, or need detox.

Inclusion Criteria

Meets CDC PrEP eligibility criteria

Is HIV-negative (confirmed through a test at baseline)

Screens positively for at-risk alcohol use

Exclusion Criteria

I do not speak English.

Score of 23 or greater on the Alcohol Withdrawal Symptom Checklist

History of active psychosis or severe mental illness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the TRAC-ER intervention, which includes EMI messaging, TRAC sessions, and smartphone-based alcohol monitoring

8 months

Ongoing monitoring via smartphone app

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• TRAC-ER

Trial Overview The study tests the TRAC-ER app intervention that combines GPS tracking with ecological momentary interventions (EMI) to reduce risky alcohol use. When participants visit 'risky' places, they receive messages encouraging strategies from prior sessions and provide data on their drinking behavior.

Participant Groups

Group I: TRAC-ER plus SAM Experimental Treatment 3 Interventions

Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention combined with GPS-based ecological momentary interventions (EMI) and smartphone-based alcohol monitoring.

Group II: TRAC plus SAM Experimental Treatment 2 Interventions

Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.

Group III: SAM-Only Comparison Group Experimental Treatment 1 Intervention

Participants in this group will engage only in smartphone-based alcohol monitoring.

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

Carolyn Lauckner

Lead Sponsor

Trials

3

Recruited

500+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

The Location-Based Monitoring and Intervention System for Alcohol Use Disorders (LBMI-A) was evaluated through qualitative interviews with 26 participants after a 6-week pilot study, highlighting its effectiveness in promoting awareness and accountability in managing alcohol use.

Users identified five key helpful features of the LBMI-A app: awareness of alcohol use, accountability for behaviors, transference of coping skills, tracking progress, and receiving prompts, suggesting these elements are crucial for the success of smartphone-based interventions for alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining perceptions of a smartphone-based intervention system for alcohol use disorders. Giroux, D., Bacon, S., King, DK., et al.[2022]

A pilot study involving 21 OEF/OIF veterans showed that the Step Away app was easy to use and helped increase users' awareness of their alcohol consumption, which is crucial for reducing unhealthy drinking habits.

Participants appreciated features like daily assessments and personalized feedback, indicating that these elements could enhance engagement and motivate users to change their drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. veterans' experiences and factors associated with use of a smartphone application to self-manage unhealthy alcohol use. Hawkins, EJ., Lott, AM., Danner, AN., et al.[2023]

The smartphone-based intervention aimed at reducing risky drinking in young adults did not significantly decrease risky drinking behaviors or related harms, based on a pilot study involving 45 participants.

However, the intervention successfully increased the use of protective behavioral strategies among users, and participants rated the app as highly usable, indicating potential for future improvements in harm-minimization approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Personalized Protective Behavioral Drinking Strategies via a Smartphone Intervention: a Pilot Study. O'Donnell, R., Richardson, B., Fuller-Tyszkiewicz, M., et al.[2020]

A new smartphone-based intervention system was developed to help individuals with alcohol use disorders by providing immediate, self-administered assessments and interventions.

The design of this app was based on both theoretical frameworks and empirical evidence, ensuring that it includes effective components like assessments and feedback to enhance user engagement and promote positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based, Self-Administered Intervention System for Alcohol Use Disorders: Theory and Empirical Evidence Basis. Dulin, PL., Gonzalez, VM., King, DK., et al.[2021]

The Animated Alcohol Assessment Tool (AAA-Tool) was well-received by both patients and healthcare practitioners in Russia, with high user satisfaction ratings and a majority recommending it for broader use.

The tool provided plausible assessments of alcohol consumption, reflecting the typical vessels and beverages used by patients, indicating its potential effectiveness in facilitating alcohol screening and intervention in primary healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study to evaluate usability and acceptability of the 'Animated Alcohol Assessment Tool' in Russian primary healthcare. Wiemker, V., Bunova, A., Neufeld, M., et al.[2022]

Mobile technology-based interventions show promise in helping adults reduce or cease harmful alcohol use, with eight studies indicating positive effects despite variations in design and target populations.

Further research is needed to determine the optimal duration and frequency of these interventions, as well as to compare their effectiveness with traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. Fowler, LA., Holt, SL., Joshi, D.[2022]

A study assessing mobile apps for alcohol use found that very few effectively promote behavior change or recovery, with most only tracking consumption rather than providing evidence-based treatment components.

Despite the potential of mobile technology to aid in alcohol intervention, there is a significant lack of empirical support for the claims made by many apps, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting behavior change from alcohol use through mobile technology: the future of ecological momentary assessment. Cohn, AM., Hunter-Reel, D., Hagman, BT., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Examining perceptions of a smartphone-based intervention system for alcohol use disorders. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

U.S. veterans' experiences and factors associated with use of a smartphone application to self-manage unhealthy alcohol use. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Delivering Personalized Protective Behavioral Drinking Strategies via a Smartphone Intervention: a Pilot Study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Smartphone-Based, Self-Administered Intervention System for Alcohol Use Disorders: Theory and Empirical Evidence Basis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot study to evaluate usability and acceptability of the 'Animated Alcohol Assessment Tool' in Russian primary healthcare. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Promoting behavior change from alcohol use through mobile technology: the future of ecological momentary assessment. [2022]