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

132 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators propose to examine mornings after drinking as an optimal time to provide repeated, personalized feedback, with the goal of reducing hazardous drinking. Specifically, the investigators will further develop and pilot test a novel theory-based personalized feedback intervention (PFI) for heavy drinking young adults. Intervention strategies include personalized feedback (e.g., feedback on prior night blood alcohol concentration, consequences) contrasted with both drinking goals set at baseline and corrective normative feedback (e.g., how last night's drinking compares to peers). Up to 170 participants (50% non-college) will be randomized to one of three groups: PFI with monetary incentives for daily surveys, PFI without monetary incentives, or survey assessment only. The investigators will examine recruitment rates, retention rates, confirmation of intervention content delivery/intake, response rates to daily surveys, data quality, and ratings of intervention value. Investigators will test whether these indicators of engagement differ between those who do and do not receive monetary incentives for daily surveys. Further, baseline, post-test, and 3-month follow-up assessments will allow us to examine differences in drinking behavior between PFI and control. The results of the proposed research will result in a novel and scalable intervention for alcohol misuse among young adults, with potential to have an important impact on the public health problem of high-risk drinking.

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 data supports the effectiveness of the treatment Mobile-delivered personalized feedback for alcohol consumption?

Research shows that smartphone apps with personalized feedback, like the Drink Less app, can help reduce alcohol consumption. Enhanced features such as Normative Feedback and Self-monitoring were found to improve alcohol-related outcomes, suggesting that mobile-delivered personalized feedback can be effective. ^{1 2 3 4 5}

Is mobile-delivered personalized feedback for alcohol consumption safe for humans?

The studies reviewed do not report any safety concerns related to mobile-delivered personalized feedback for alcohol consumption, suggesting it is generally safe for use in humans. ^{6 7 8 9 10}

How does the mobile-delivered personalized feedback treatment for alcohol consumption differ from other treatments?

This treatment is unique because it uses mobile technology to provide personalized feedback in real-time, allowing individuals to self-monitor and receive immediate guidance on their alcohol consumption. Unlike traditional methods, it offers a portable and self-administered approach, making it more accessible and engaging for users. ^{1 2 11 12 13}

Research Team

Jennifer E Merrill, PhD

Principal Investigator

Brown University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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

A smartphone app to reduce excessive alcohol consumption: Identifying the effectiveness of intervention components in a factorial randomised control trial. [2023]

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

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. [2023]

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

In-person alcohol counseling versus computer-generated feedback: Results from a randomized controlled trial. [2018]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Keeping Track of My Drinking - Patient Perceptions of Using Smartphone Applications as a Treatment Complement for Alcohol Dependence. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up results from a randomized controlled trial of a brief personalized feedback intervention for problem drinkers. [2021]

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

Personalized feedback based on a drink-pouring exercise may improve knowledge of, and adherence to, government guidelines for alcohol consumption. [2019]

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

Internet-based personalized feedback to reduce 21st-birthday drinking: a randomized controlled trial of an event-specific prevention intervention. [2022]

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

Detecting Drinking Episodes in Young Adults Using Smartphone-based Sensors. [2022]

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

What Should We Do When Participants Report Dangerous Drinking? The Impact of Personalized Letters Versus General Pamphlets as a Function of Sex and Controlled Orientation. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Curbing alcohol use in male adults through computer generated personalized advice: randomized controlled trial. [2021]

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

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

13. England pubmed.ncbi.nlm.nih.gov

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