Feedback Interventions + Text Messages for Alcohol Use Disorder

(MC2 Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

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

Compensation: Varies

Number of Visits: 29

1012 Participants Needed

Trial Summary

What is the purpose of this trial?

The study evaluates the relative merit of a multi-component PFI presented in the traditional simultaneous delivery (i.e., all components at once) versus a sequential format, wherein individual PFI components are delivered one at a time over several weeks to minimize time and attention demands for each component.

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 this treatment for Alcohol Use Disorder?

Research shows that personalized feedback interventions can effectively reduce harmful alcohol use, especially among college students. These interventions provide individuals with information about their drinking habits compared to others, which can help them make healthier choices. ^{1 2 3 4 5}

Is the combination of feedback interventions and text messages for alcohol use disorder safe for humans?

The research articles reviewed do not provide specific safety data for the combination of feedback interventions and text messages for alcohol use disorder. However, personalized feedback interventions have been widely used in various studies without reported safety concerns, suggesting they are generally safe for human use. ^{1 2 3 4 6}

How does the Feedback Interventions + Text Messages treatment for Alcohol Use Disorder differ from other treatments?

This treatment is unique because it combines personalized feedback with supportive text messages to help reduce alcohol consumption. The feedback provides individuals with insights into their drinking habits, while the text messages offer ongoing support and motivation, making it a more interactive and personalized approach compared to traditional methods. ^{1 4 7 8 9}

Research Team

Mary E Larimer, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

References

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

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

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

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

3. 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]

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

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Curbing problem drinking with personalized-feedback interventions: a meta-analysis. [2022]

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

Using national alcohol screening day to deliver personalized feedback: a pilot study. [2017]

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

Alcohol Use Disorder and Comorbid Depression: A Randomized Controlled Trial Investigating the Effectiveness of Supportive Text Messages in Aiding Recovery. [2020]

8. Canada 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. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Six-months outcomes of a randomised trial of supportive text messaging for depression and comorbid alcohol use disorder. [2018]