Feedback Interventions + Text Messages for Alcohol Use Disorder

(MC2 Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Unwillingness, No consent, Travel plans, others

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

Compensation: Varies

Number of Visits: 29

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for delivering personalized feedback to assist individuals with alcohol use disorder. Researchers are testing whether providing all feedback at once or spreading it over several weeks, sometimes with additional support through text messages, is more effective. Individuals who have experienced at least one heavy drinking episode in the past month and have faced some negative consequences from drinking may be suitable candidates. Participants must have a cell phone capable of receiving text messages. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in managing alcohol use disorder.

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 personalized feedback interventions (PFI) are generally safe and well-received. Studies on delivering these interventions simultaneously indicate they are practical and acceptable to participants, with no major safety issues reported. Similar studies on sequential delivery have found them effective and safe for addressing high-risk drinking without significant side effects.

Text message reminders, used alongside feedback interventions, are also considered safe. Research indicates they help reduce alcohol consumption with minimal safety concerns.

Overall, these interventions have been used successfully in various settings, suggesting they are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to deliver personalized feedback and support through text messages to help individuals with Alcohol Use Disorder (AUD). Unlike traditional treatments that might rely solely on therapy or medication, this approach uses technology to provide real-time, personalized interventions. The trial investigates both simultaneous and sequential delivery methods, with some groups receiving immediate in-depth feedback and others receiving it over time, paired with text message support. This trial aims to find out whether these personalized and tech-driven methods can more effectively reduce high-risk drinking behaviors compared to existing options.

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

Research has shown that personalized feedback interventions (PFIs) can help reduce alcohol use. In this trial, participants will receive PFIs either all at once or in steps over time. Studies have found that delivering PFIs all at once, especially online, can lower alcohol consumption among college students, with one study noting a decrease of 1.65 drinks per week. PFIs given in steps over time also effectively reduce binge drinking and are designed to be less time-consuming and easier to follow. Some participants in this trial will also receive text message boosters, which have shown promise in further reducing alcohol use by offering timely reminders and support. Overall, these interventions have successfully helped people drink less. ^{6 7 8 9 10}

Who Is on the Research Team?

Mary E Larimer, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This study is for individuals who have experienced negative consequences from alcohol use, as measured by specific tests, and engage in heavy drinking episodes. Participants must own a cell phone capable of receiving text messages and be willing to receive them. Those planning international travel soon or unwilling to consent are excluded.

Inclusion Criteria

You have consumed a large amount of alcohol in a short period of time at least once in the past month.

Indicate they own a cell phone with text message capabilities and consent to receiving text messages

At least 2 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past month for cohort 2 - 5

Exclusion Criteria

I am willing to participate in the clinical trial.

Failure to provide consent

Plan to travel internationally in the next 12 months (for intervention text purposes)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline and Intervention

Participants receive either simultaneous or sequential delivery of feedback components and complete a baseline survey

4 weeks

4 visits (virtual)

Follow-up

Participants complete follow-up surveys to assess knowledge and changes in alcohol use

24 months

Multiple assessments over 24 months

Event-specific Monitoring

Participants' alcohol use is monitored during high-risk events such as Halloween, 4th of July, and Spring Break

Varies by event

What Are the Treatments Tested in This Trial?

Interventions

• Sequential Personalized Feedback Intervention Delivery
• Sequential Post Feedback Intervention Delivery
• Simultaneous Personalized Feedback Intervention Delivery
• Simultaneous Post Feedback Intervention Delivery
• Text Message Boosters

Trial Overview The trial is testing two ways of delivering feedback on alcohol use: all at once (traditional) versus over several weeks (sequential). It also examines the effectiveness of follow-up text message boosters in influencing participants' behavior regarding alcohol consumption.

How Is the Trial Designed?

Group I: Simultaneous Post Feedback Information Delivery +Text Messages Experimental Treatment 2 Interventions

Participants receive all 4 feedback components immediately after providing consent to the Pilot Feasibility Study following the Screening/Baseline Survey. Participants complete a brief 10 minute Post-Feedback Survey and a 3 Week Followup Survey to assess knowledge of the intervention feedback content. Additionally, participants receive the Text Message Booster Component in the days before and during the high risk drinking event celebration(s).

Group II: Simultaneous Post Feedback Information Delivery Experimental Treatment 1 Intervention

Participants receive all 4 feedback components immediately after providing consent to the Pilot Feasibility Study following the Screening/Baseline Survey. Participants complete a brief 10 minute Post-Feedback Survey and a 3 Week Followup Survey to assess knowledge of the intervention feedback content.

Group III: Sequential Post Feedback Information Delivery +Text Messages Experimental Treatment 2 Interventions

Participants receive the first component of their PFI immediately following Baseline and subsequently receive 1 component each week until they receive all 4 components. Participants will complete a Post Feedback Survey and a 3 week follow back and Knowledge assessment. Additionally, participants receive the Text Message Booster Component in the days before and during the high risk drinking event celebration(s).

Group IV: Sequential Post Feedback Information Delivery Experimental Treatment 1 Intervention

Participants receive the first component of their PFI immediately following Baseline and subsequently receive 1 component each week until they receive all 4 components. Participants will complete a Post Feedback Survey and a 3 week follow back and Knowledge assessment.

Group V: Assessment Only Control Active Control 1 Intervention

Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

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]

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]

The TRAC2 text message intervention effectively engaged nontreatment-seeking young adults, with an average response rate of 82% to ecological momentary assessments (EMAs) during the first 4-week block, indicating strong participant involvement.

Participants showed high commitment to drinking limit goals (96% commitment rate) and achieved their goals 89% of the time, suggesting that the intervention successfully supported self-regulation and reduced alcohol consumption over a 3-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Text Message Intervention with Adaptive Goal Support to Reduce Alcohol Consumption Among Non-Treatment-Seeking Young Adults: Non-Randomized Clinical Trial with Voluntary Length of Enrollment. Suffoletto, B., Chung, T., Muench, F., et al.[2020]

Personalized drinking feedback interventions (PFIs) are effective in reducing harmful alcohol misuse among college students, based on a comprehensive review of 41 studies.

Interventions that included components like decisional balance, practical costs, and risk-limiting strategies showed significantly larger effects, highlighting the importance of these elements in developing effective feedback-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Miller, MB., Leffingwell, T., Claborn, K., et al.[2022]

In a study involving 121 participants from a community substance use disorder clinic, personalized feedback interventions did not show any significant benefits in reducing alcohol consumption compared to standard pre-treatment assessment procedures.

The results indicated that feedback-based brief interventions were ineffective in improving outcomes such as drinking frequency, intensity, or motivation for treatment among individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Feedback-Based Brief Intervention to Reduce Alcohol Use in Community Substance Use Disorders. Worden, BL., McCrady, BS.[2021]

Citations

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Main Outcomes of M-Bridge: A Sequential Multiple ... A technology-based strategy to deliver targeted resource-light interventions for heavy drinkers may be effective for reducing binge drinking during the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3686515/

Effectiveness of a Feedback-Based Brief Intervention to ... Feedback brief interventions for alcohol use problems have been highly effective with undergraduate populations. However, there has been little research on ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460325000024

When less is more: Short-Term efficacy of a gamified ... This study examined the short-term effects of CampusGandr, a mobile gamified PNF intervention for college students.

4. researchgate.net researchgate.net/publication/379725304_Effectiveness_of_web-based_personalised_feedback_interventions_for_reducing_alcohol_consumption_among_university_students_A_systematic_review_and_meta-analysis

A systematic review and meta-analysis | Request PDF Effectiveness of web-based personalised feedback interventions for reducing alcohol consumption among university students: A systematic review ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/6/8/e011473

How effective are brief interventions in reducing alcohol ... Some evidence shows that computer-delivered interventions with personalised feedback can effectively reduce alcohol consumption at short-term and long-term ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8119384/

Computer-Delivered Personalized Feedback Intervention ... This study aimed to evaluate the feasibility, acceptability, and initial efficacy of a single session remotely-delivered personalized feedback intervention ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4432858/

Electronic Feedback in College Student Drinking ... Several efficacious programs using one-on-one brief intervention techniques have been developed to target high-risk drinking by individual students.

8. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714423002471

Study protocol for a sequential multiple assignment ... A randomized controlled trial of a web-based personalized normative feedback alcohol intervention for young adult veterans. Journal of Consulting and ...

9. 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.

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/add.16522

Web‐based intervention for young adults experiencing ... A fully integrated treatment for comorbid social anxiety disorder and alcohol use disorder in a community-based SUD clinic setting.