Digital Motivational Intervention for Risky Drinking

(Horizons Trial)

Overseen By Manju Karki, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Age out of range, Fulltime college students, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adults in disadvantaged communities find alternatives to heavy drinking. It uses a web-based program to encourage thinking about the future and engaging in positive activities instead of risky drinking. Participants might receive motivation-focused strategies through the Motivational Behavioral Economic Alcohol Intervention or general health education materials. Young adults aged 18 to 28, not enrolled in a full-time 4-year college, and who have experienced recent heavy drinking episodes with negative consequences may qualify for this trial. Participants need internet access and at least an 8th-grade education.

As an unphased trial, this study offers a unique opportunity to explore new strategies for healthier living.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that motivational programs, like the one in this study, have helped college students reduce their drinking. These programs encourage thinking about the future and engaging in enjoyable activities instead of drinking.

Past studies found these programs to be generally safe, with participants not reporting any serious side effects. The main goal is to promote healthier choices without causing harm or discomfort.

This trial uses a digital platform to deliver the program, building on methods already proven safe. Since no medication is involved, the risk of side effects is usually lower. The focus is on changing behavior through motivation and practical ideas, making it a low-risk option for those interested in joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Motivational Behavioral Economic Alcohol Intervention because it offers a fresh approach to reducing risky drinking through a web-based platform. Unlike traditional treatments such as counseling or medication, this intervention uses motivational strategies combined with behavioral economics, which may encourage more sustainable changes in drinking behavior. The digital format makes it accessible and convenient, allowing individuals to engage with the intervention at their own pace and from any location. Additionally, the focus on personalized motivation and economic principles aims to make the intervention more engaging and effective, potentially reaching individuals who might not seek out conventional treatment options.

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

This trial will compare a Motivational Behavioral Economic Intervention with Health Education to reduce risky drinking. Research has shown that short motivational sessions, like those in the Motivational Behavioral Economic Intervention, can help reduce risky drinking among college students. These sessions aim to increase students' awareness of drinking effects and encourage healthier choices. Studies have found that these methods assist young adults who drink heavily by offering alternatives to alcohol and helping them plan for the future. This approach is based on the idea that providing enjoyable, non-drinking activities can lower alcohol use. Early results suggest this method could effectively help people in disadvantaged communities with risky drinking. ^{1 2 4 6 7}

Who Is on the Research Team?

Jalie A Tucker, PhD, MPH

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for non-college adults aged 18-28 in North and Central Florida who drink more than the recommended safe limits and have faced negative consequences from drinking. They must have web access, at least an 8th-grade education, and can't be blood relatives of previous participants or full-time college students.

Inclusion Criteria

I am 18-28, not in a 4-year college full-time, and live in a disadvantaged area in North/Central Florida.

Web access via smartphone or computer

Past 30-day alcohol use exceeding NIAAA (2005) single day limits for lower risk drinking (4 drinks for males; 3 drinks for women) and one or more alcohol-related negative consequences in the past 90 days

Exclusion Criteria

My age does not fit the trial's requirements.

Education less than 8th grade

Lack of smartphone or computer availability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a web-based alcohol risk reduction brief intervention or health education material

1 month

Digital platform access

Follow-up

Participants are monitored for changes in drinking behavior and related outcomes

12 months

Assessments at 1, 6, and 12 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• Motivational Behavioral Economic Alcohol Intervention

Trial Overview The study tests a digital intervention designed to reduce risky drinking by promoting future-oriented thinking and pro-social activities as alternatives to alcohol use. It's a randomized trial where some get this new motivational program while others receive standard health education.

How Is the Trial Designed?

Group I: Motivational Behavioral Economic Intervention Experimental Treatment 1 Intervention

Web-based alcohol risk reduction brief intervention

Group II: Health Education Active Control 1 Intervention

Web-based health education material

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study involving 602 patients with substance use disorders who used the reSET® digital therapeutic, there was a high engagement level, with a median of 33 out of 61 lessons completed and 52% of patients finishing all core modules.

The treatment showed promising outcomes, with a retention rate of 74% during the last four weeks and 62% of patients achieving abstinence by the end of the 12-week program, indicating the potential effectiveness of digital therapeutics in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. Xiong, X., Braun, S., Stitzer, M., et al.[2023]

A randomized controlled trial with 185 recently resolved untreated problem drinkers showed that those who actively used the supportive interactive voice response (IVR) self-monitoring program were more likely to achieve moderation in drinking, especially if they had shorter time horizons regarding their spending on alcohol versus savings.

While the IVR program did not show overall effects in intention-to-treat analyses, individual differences in drinking control and reward preferences were important predictors of success, suggesting that personalized approaches may enhance the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of interactive voice response self-monitoring on natural resolution of drinking problems: utilization and behavioral economic factors. Tucker, JA., Roth, DL., Huang, J., et al.[2021]

The 'Steering Clear First Offender Drink Driving Program' was piloted with 15 first-time drink driving offenders, who found the online intervention user-friendly and engaging, indicating its potential for wider application.

Participants reported that the program's content was relevant and useful, particularly in understanding the consequences of drink driving, suggesting that digital interventions can effectively address risky alcohol-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steering Clear of Driving After Drinking: a Tailored e-Health Intervention for Reducing Repeat Offending and Modifying Alcohol Use in a High-Risk Cohort. Wilson, HJ., Palk, G., Sheehan, MC., et al.[2022]

In a study involving 672 participants using the Drink Less app, older users and those with post-16 educational qualifications showed higher engagement and were more likely to respond to follow-up assessments after one month.

While higher baseline alcohol consumption was linked to greater reductions in alcohol intake, engagement with the app did not correlate with the extent of alcohol reduction, indicating that simply using the app more did not necessarily lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Engagement, Response to Follow Up, and Extent of Alcohol Reduction in Users of a Smartphone App (Drink Less): Secondary Analysis of a Factorial Randomized Controlled Trial. Garnett, C., Perski, O., Tombor, I., et al.[2022]

Experts identified twelve behavior change techniques (BCTs) that could effectively reduce alcohol consumption, with self-monitoring, goal-setting, action planning, and feedback being the most highly rated.

Engagement strategies for a smartphone app were also ranked, with the top strategies being ease of use, appealing design, tailored information, and unique smartphone features, indicating a focus on user experience to enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Behavior Change Techniques and Engagement Strategies to Design a Smartphone App to Reduce Alcohol Consumption Using a Formal Consensus Method. Garnett, C., Crane, D., West, R., et al.[2022]

Motivational interviewing (MI) is effective for encouraging health behavior change, particularly in risky substance use, but current measures of client language during sessions need refinement to improve outcomes.

Preliminary findings from a pilot study suggest that integrating behavioral economic (BE) principles with MI may enhance the prediction of behavior change in college students, indicating that BE-informed measures of client language could be more effective than traditional MI measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of motivational interviewing and behavioral economic theories to enhance brief alcohol interventions: Rationale and preliminary examination of client language. Ladd, BO., Murphy, JG., Borsari, B.[2022]

A randomized controlled trial involving 320 risky drinkers found that a digital brief intervention (BI) was not inferior to traditional face-to-face BI in reducing risky drinking behaviors after 3 months.

Despite the digital intervention showing similar effectiveness, the study faced limitations due to low participant recruitment and follow-up, indicating a need for improved strategies to implement digital interventions in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain). Caballeria, E., López-Pelayo, H., Segura, L., et al.[2023]

A randomized controlled trial involving 82 first-year college students showed that combining a standard alcohol brief motivational interviewing (BMI) session with a Substance-Free Activity Session (SFAS) led to significantly greater reductions in alcohol-related problems at both 1-month and 6-month follow-ups.

The SFAS, which emphasizes engaging in rewarding substance-free activities, was particularly effective for participants with low levels of substance-free reinforcement or symptoms of depression, suggesting that enhancing alternative rewards can improve the efficacy of alcohol interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a behavioral economic supplement to brief motivational interventions for college drinking. Murphy, JG., Dennhardt, AA., Skidmore, JR., et al.[2022]

In a review of 41 randomized control trials on digital behavior change interventions (DBCIs) for reducing alcohol consumption, techniques like 'Behavior substitution,' 'Problem solving,' and 'Credible source' were linked to significantly greater reductions in alcohol intake.

The average intervention used 9.1 behavior change techniques, but many effective techniques, such as 'Self-monitoring' and 'Goal setting,' were used infrequently, suggesting that incorporating a wider range of techniques could enhance the effectiveness of DBCIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques Used in Digital Behavior Change Interventions to Reduce Excessive Alcohol Consumption: A Meta-regression. Garnett, CV., Crane, D., Brown, J., et al.[2022]

A pilot study involving 13 college freshmen showed that a 50-minute Substance-Free Activity Session (SFAS) effectively reduced heavy drinking and weekly alcohol consumption after one month.

The SFAS aims to enhance the appeal of delayed rewards, like academic success, which may help participants engage in healthier behaviors and reduce alcohol use, suggesting it could be a valuable addition to traditional alcohol interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral economic supplement to brief motivational interventions for college drinking. Murphy, JG., Skidmore, JR., Dennhardt, AA., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05443750

Digital Motivational Behavioral Economic Intervention to ... Guided by behavioral economics, this cluster randomized controlled trial will evaluate a brief behavioral intervention aimed at increasing future orientation ...

2. reporter.nih.gov reporter.nih.gov/search/f4XhO_EEUkSiDebr6xAD-A/project-details/11170607

Project Details - NIH RePORTER Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults. Project Number5R01AA028230-05. Former ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3770470/

A behavioral economic supplement to brief motivational ... Basic behavioral and neurobiological research has demonstrated that deficiencies in naturally occurring substance-free rewards are both a cause and a ...

4. mdpi.com mdpi.com/2227-9032/13/19/2405

Motivational Interventions for Reducing Excessive Alcohol ... Background/Objectives: University students frequently engage in risky alcohol consumption, making them a priority population for targeted interventions.

5. clinicaltrial.be clinicaltrial.be/fr/details/16257?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Digital Motivational Behavioral Economic Intervention to... Brief motivational interventions (BMIs) to reduce risky drinking in college students are well established as beneficial, but the needs of ...

6. reporter.nih.gov reporter.nih.gov/project-details/7586257

murphy, james g. - NIH RePORTER Heavy drinkers are less engaged in academics, community service, and other constructive aspects of college life. Although brief motivational interventions (BMIs) ...

7. withpower.com withpower.com/trial/digital-motivational-intervention-for-risky-drinking-0d46a

Digital Motivational Intervention for Risky Drinking (Horizons Trial) Trial Overview The study tests a digital intervention designed to reduce risky drinking by promoting future-oriented thinking and pro-social activities as ...