Personalized Feedback for Alcohol Consumption

((A-FRAME) Trial)

Overseen By Jennifer E Merrill, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Current substance treatment, Prior study participation, Others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce risky drinking behaviors by providing young adults with mobile-delivered personalized feedback after they drink. Participants will receive feedback on their blood alcohol levels and the consequences of their drinking, compared to their drinking goals and peers. The study will test whether adding monetary incentives for completing daily surveys enhances the feedback's effectiveness. Ideal candidates are young adults who drink heavily at least once a week and have experienced negative effects from drinking. Participants must also be open to slightly reducing their alcohol intake.

As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could lead to new strategies for reducing risky drinking behaviors.

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 focuses on alcohol consumption and does not mention medication restrictions.

What prior data suggests that this personalized feedback intervention is safe for reducing hazardous drinking?

Research has shown that using mobile apps to provide personalized feedback on alcohol use is generally safe. Studies have not identified any safety issues with this approach. Tailored feedback through mobile devices may help individuals reduce heavy drinking more effectively than doing nothing or offering only general health tips. Most studies report positive outcomes without major problems. This suggests that mobile feedback is well-tolerated and could be a safe option for those seeking to reduce their alcohol intake. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a new way to tackle alcohol consumption using technology. Unlike traditional approaches, which often involve in-person counseling or medication, this method delivers personalized feedback directly to your mobile device, making it more accessible and convenient. There are two variations being explored: one includes a daily incentive to encourage participation, while the other does not. This approach could provide instant, tailored support to help individuals reduce their drinking habits, potentially transforming the way we approach alcohol intervention.

What evidence suggests that this personalized feedback intervention is effective for reducing hazardous drinking?

Research has shown that personalized feedback on phones can help reduce alcohol consumption. In this trial, participants in the "Personalized feedback plus incentive" group will receive personalized feedback after each daily survey indicating prior day drinking, along with a $1 incentive for submitting their survey. Participants in the "Personalized feedback without incentive" group will receive the same feedback without the monetary incentive. One study found that people using a smartphone app to track their drinking reduced their alcohol use more over six months than those who didn't use the app. Another review found that mobile health apps help adults in developed countries drink less. Personalized feedback, especially when given immediately after drinking, helps people understand their drinking habits and how they compare to others. This approach encourages better drinking choices by providing immediate and relevant information. Overall, mobile apps appear promising for those wanting to cut down on drinking. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer E Merrill, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-29 who frequently engage in heavy drinking, own and use a smartphone daily, have experienced negative consequences from drinking, and are at least somewhat open to reducing their alcohol intake.

Inclusion Criteria

Own a smartphone and use it daily

Heavy episodic drinking (4+/5+ drinks for women/men) at least weekly in past month

At least one of 10 negative consequences assessed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Baseline Assessment and Orientation

Participants complete a baseline survey and orientation meeting to describe study procedures and obtain informed consent

1 week

1 visit (virtual)

Randomization and Intervention

Participants are randomized into groups and undergo four weeks of daily assessments and personalized feedback interventions

4 weeks

Daily virtual assessments

Post-Intervention Follow-up

Participants complete a post-intervention survey to assess primary outcomes

1 week

1 visit (virtual)

3-Month Follow-up

Participants complete a follow-up survey three months after the end of the intervention to assess long-term outcomes

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mobile-delivered personalized feedback

Trial Overview The study tests a mobile app that gives personalized feedback the morning after drinking. Participants will be randomly placed into three groups: one with incentives for daily surveys plus feedback, one with just feedback, and one only taking surveys.

How Is the Trial Designed?

Group I: Personalized feedback without incentive Experimental Treatment 1 Intervention

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will NOT receive $1 per day for submitting their daily survey.

Group II: Personalized feedback plus incentive Experimental Treatment 1 Intervention

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will receive $1 per day for submitting their daily survey.

Group III: Control Active Control 1 Intervention

Participants in this arm will only complete baseline and follow-up surveys.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Individuals who consume higher amounts of alcohol are more likely to choose to receive personalized feedback about their drinking habits, with 85% of participants consistently opting in across two time points.

Receiving feedback led to a small reduction in peak alcohol consumption among heavy drinkers over a 30-day period, suggesting that personalized interventions may help reduce drinking intensity, although further research is needed to confirm these findings in more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. Boness, CL., Helle, AC., Miller, MB., 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]

A study involving 5476 Brazilian college students found that the components of personalized normative feedback (PNF) did not significantly reduce alcohol use or its consequences compared to the full intervention, with some evidence suggesting adverse effects, particularly among less motivated participants.

The normative feedback only (NFO) and consequences feedback only (CFO) components showed some short-term benefits in reducing alcohol use and frequency, but they also led to an increase in the number of typical drinks consumed over time, indicating a complex relationship between feedback and drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design. Bedendo, A., McCambridge, J., Gaume, J., et al.[2021]

Participants in a study of 21 individuals with alcohol dependence found that self-monitoring apps like 'Glasklart' and 'iBAC' helped increase awareness of their drinking habits and motivated them to change, enhancing their treatment experience.

Despite the benefits, the use of these apps was hindered by technical issues and feelings of shame related to alcohol use, suggesting that while they can be effective tools, improvements are needed for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keeping Track of My Drinking - Patient Perceptions of Using Smartphone Applications as a Treatment Complement for Alcohol Dependence. Östh, J., Danielsson, AK., Lundin, A., et al.[2023]

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]

Citations

1. cureus.com cureus.com/articles/397462-the-effectiveness-of-mobile-health-mhealth-in-reducing-alcohol-consumption-among-adults-in-developed-countries-a-systematic-review.pdf?email=

The Effectiveness of Mobile Health (mHealth) in Reducing ... This systematic review evaluated the effectiveness of mobile health (mHealth) applications in reducing alcohol consumption among adults in ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/08897077.2022.2074595

Full article: Smartphone-based alcohol interventions The aim of this review was to assess the role of notifications in smartphone-based interventions designed to support, manage, or reduce alcohol consumption.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4432850/

Mobile Delivery of Treatment for Alcohol Use Disorders Text-messaging monitoring and reminder systems deliver reminders and prompt reporting of alcohol consumption, enabling continuous monitoring of alcohol use.

4. sciencedirect.com sciencedirect.com/science/article/pii/S221478292400040X

Randomized controlled trial of a smartphone app designed ... Participants who received the full app reported a greater reduction in their alcohol consumption between baseline and 6-month follow-up compared to ...

5. mhealth.jmir.org mhealth.jmir.org/2020/5/e16937/

Assessment of the Efficacy of a Mobile Phone–Delivered Just ... A mobile phone–delivered, just-in-time, if-then planning intervention to practice sensible drinking with friends or when going out is effective in reducing ...

6. withpower.com withpower.com/trial/personalized-feedback-for-alcohol-consumption-a192d

Personalized Feedback for Alcohol Consumption Is mobile-delivered personalized feedback for alcohol consumption safe for humans? The studies reviewed do not report any safety concerns related to mobile ...

7. cureus.com cureus.com/articles/397462-the-effectiveness-of-mobile-health-mhealth-in-reducing-alcohol-consumption-among-adults-in-developed-countries-a-systematic-review

The Effectiveness of Mobile Health (mHealth) in Reducing ... This review analysed ten recent mHealth studies targeting alcohol reduction, with nine showing positive outcomes. Mobile applications proved ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6240004/

A Mobile Phone–Based Brief Intervention With ... Students receiving the mobile phone–based DAD intervention would report greater reductions in driving after drinking (three or more drinks) at 3-month follow-up ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6483779/

Personalised digital interventions for reducing hazardous and ... Personalised advice using computers or mobile devices may help people reduce heavy drinking better than doing nothing or providing only general health ...

10. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02374-5

Effectiveness of a digital intervention versus alcohol ... The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers.