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

806 Participants Needed

Trial Summary

What is the purpose of this trial?

Emerging adult risky drinkers living in disadvantaged communities often have limited access to rewarding activities and adult roles that offer alternatives to heavy drinking. Guided by behavioral economics, this cluster randomized controlled trial will evaluate a brief behavioral intervention aimed at increasing future orientation and engaging pro-social alternatives to drinking delivered using a peer-driven sampling method and digital platform well suited for accessing their social networks.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Digital Motivational Intervention for Risky Drinking treatment?

Research shows that adding a behavioral economic session to traditional alcohol interventions can significantly reduce heavy drinking among college students. Additionally, digital interventions for alcohol reduction have been found to be as effective as face-to-face interventions in primary care settings, suggesting that digital approaches can be a viable option for reducing risky drinking. ^{1 2 3 4 5}

Is the Digital Motivational Intervention for Risky Drinking safe for humans?

The research articles do not provide specific safety data for the Digital Motivational Intervention for Risky Drinking, but they suggest that digital interventions for alcohol reduction are generally considered acceptable and user-friendly. ^{1 5 6 7 8}

How is the Digital Motivational Behavioral Economic Alcohol Intervention treatment different from other treatments for risky drinking?

This treatment is unique because it uses a digital platform to deliver motivational and behavioral strategies, making it more accessible and potentially more cost-effective than traditional face-to-face interventions. It aims to engage users through digital means, which can overcome barriers to implementation in clinical settings. ^{2 5 6 9 10}

Research Team

Jalie A Tucker, PhD, MPH

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

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

A behavioral economic supplement to brief motivational interventions for college drinking. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain). [2023]

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

Effects of interactive voice response self-monitoring on natural resolution of drinking problems: utilization and behavioral economic factors. [2021]

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

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. [2023]

5. Canada 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. [2022]

6. England 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. [2022]

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

A randomized controlled trial of a behavioral economic supplement to brief motivational interventions for college drinking. [2022]

8. United States 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. [2022]

9. Canada 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques Used in Digital Behavior Change Interventions to Reduce Excessive Alcohol Consumption: A Meta-regression. [2022]