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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called TRAC-ER, designed to help people manage risky alcohol use by sending supportive messages and collecting data through GPS and surveys. The app aims to reduce alcohol consumption by reminding participants to use strategies learned in sessions when near places that might trigger drinking. It also gathers information on alcohol use and behaviors related to HIV risk. Participants should own a smartphone, have experienced issues with alcohol, such as binge drinking in the past year, and be at high risk for HIV. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new ways of managing alcohol use and reducing HIV risk.

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 prior data suggests that this mobile app intervention is safe for reducing risky alcohol use?

Research has shown that the TRAC-ER program, which combines GPS tracking with real-time support messages, may help reduce risky alcohol use. Although detailed safety data specifically for TRAC-ER is not available, sending timely messages via phones is generally considered low-risk.

As an app-based program, TRAC-ER primarily involves receiving messages and completing surveys, presenting minimal physical risk compared to treatments involving medication or medical procedures. The main concern might be privacy, as the app uses GPS to track locations. However, no known health risks are associated with using this type of app.

Prospective trial participants can feel reassured knowing that app-based programs are usually well-tolerated due to their non-invasive nature. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile App Intervention for Risky Alcohol Use because it leverages technology in innovative ways to help reduce alcohol consumption. Unlike traditional treatments that might involve in-person counseling or medication, the TRAC-ER treatment combines smartphone-based alcohol monitoring with GPS-based ecological momentary interventions (EMI). This means it can provide real-time support and feedback based on a person's location and drinking habits, offering a personalized approach to managing alcohol use. By using technology to adapt to users' environments and behaviors, this method could make it easier for individuals to reduce risky drinking patterns in their daily lives.

What evidence suggests that this trial's treatments could be effective for reducing risky alcohol use?

Research shows that the TRAC program can help people reduce their drinking by boosting motivation and teaching them to handle situations that might lead to drinking. In this trial, participants in the "TRAC plus SAM" group will receive the TRAC intervention along with smartphone-based alcohol monitoring. Meanwhile, those in the "TRAC-ER plus SAM" group will receive the TRAC intervention combined with GPS-based ecological momentary interventions (EMI) and smartphone-based alcohol monitoring. Early results suggest that combining TRAC with the mobile app, TRAC-ER, could enhance its effectiveness. This app uses GPS to send helpful messages when people are near places where they might be tempted to drink excessively. A small study found that this approach might help veterans with HIV drink less, indicating potential benefits for others as well. By offering real-time support and tracking drinking habits, the TRAC-ER app aims to help people manage their triggers and reduce risky drinking. ^{1 4 6 7 8}

Who Is on the Research Team?

Carolyn Lauckner, PhD

Principal Investigator

University of Kentucky

Trace Kershaw, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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

Score of 23 or greater on the Alcohol Withdrawal Symptom Checklist

History of active psychosis or severe mental illness

I am currently in detox for substance use and require medical help.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05576350

TRAC-ER Intervention to Reduce Risky Alcohol Use and ... The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10888529/

Pilot Trial of a Smartphone-Based Intervention to Reduce ... Overall, this pilot demonstrated that the TRAC intervention has potential to reduce alcohol use among veterans with HIV, though additional effort is needed to ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05576350/trac-er-intervention-to-reduce-risky-alcohol-use-and-hiv-risk

TRAC-ER Intervention to Reduce Risky Alcohol Use and ... For this study, the investigators will enhance an existing mHealth intervention (TRAC) to reduce alcohol use among young adults at risk for HIV ...

4. withpower.com withpower.com/trial/phase-risky-behaviors-2-2023-7242d

Mobile App Intervention for Risky Alcohol Use 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 ...

5. trial.medpath.com trial.medpath.com/clinical-trial/179c1062dfaee236/evaluation-motivational-interviewing-alcohol-use

TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV ... For this study, the investigators will enhance an existing mHealth intervention (TRAC) to reduce alcohol use among young adults at risk for HIV by combining the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38578673/

Protocol for a Randomized Controlled Trial - PubMed - NIH Objective: This study will test an EMI that uses motivational interviewing (MI), smartphone surveys, mobile breathalyzers, and location tracking ...

7. uky.trialstoday.org uky.trialstoday.org/trial/NCT05576350

TRAC-ER Intervention to Reduce Risky Alcohol Use and ... 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 ...

8. researchprotocols.org researchprotocols.org/2024/1/e55166/PDF

XSL•FO The Tracking and Reducing Alcohol Consumption (TRAC) intervention, recently tested among people with HIV and currently being tested (since July ...