Personalized Feedback for Alcoholism

(D3 Trial)

Overseen By Nicole Fossos-Wong

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Not meeting inclusion criteria, others

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized online messages (personalized feedback) assist young adults in making better decisions regarding alcohol consumption. Participants will either receive health-related messages through online modules and texts or only complete surveys. The goal is to assess the usability and helpfulness of these materials. The trial seeks participants aged 18-24 in Washington State who have experienced at least one heavy drinking episode and two alcohol-related issues in the past month. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health interventions for young adults.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on alcohol use and related experiences, so it's best to ask the trial organizers for more details.

What prior data suggests that this personalized feedback is safe?

Research has shown that personalized feedback for alcohol use is generally safe and well-tolerated. Studies have found these methods effectively help people reduce problem drinking by providing customized feedback about their drinking habits, often through online modules or text messages, similar to those used in this trial.

No evidence indicates any serious negative effects from these personalized feedback methods. As they focus on education and awareness rather than medical treatments, they are considered low-risk. This trial employs approaches that past research has found effective and safe.

Overall, the risk is low, and these methods have helped many people make healthier choices about alcohol. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized feedback approach for alcoholism treatment because it offers a more tailored intervention compared to traditional methods like counseling or medication. Unlike standard options, this treatment provides personalized health information through online modules and text messages, which can be more engaging and accessible for participants. This method allows individuals to receive support and feedback in real-time, potentially leading to more immediate and meaningful behavioral changes. By leveraging technology, this personalized feedback approach could enhance motivation and adherence, offering a promising alternative to more conventional treatments.

What evidence suggests that personalized feedback is effective for alcoholism?

Research shows that personalized feedback, which participants in this trial may receive, can help reduce alcohol consumption. Some studies have found that online personalized feedback can lead to a reduction of about 1.5 drinks per week among college students. This feedback typically includes details about drinking habits and social norms, increasing awareness of alcohol use. However, other research suggests that personalized feedback sometimes offers little benefit beyond the initial assessment. Overall, while results can vary, personalized feedback has shown promise in helping people manage their drinking better. ^{1 6 7 8 9}

Who Is on the Research Team?

Brittney Hultgren, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for young adults who are dealing with alcoholism and are interested in exploring ways to have more positive experiences if they choose to drink. Specific eligibility criteria details were not provided, so it's assumed that participants should be willing to engage with online modules and text messages.

Inclusion Criteria

At least 1 occurrence of heavy drinking in the past month

Agree to be randomized to receive intervention to assessment only control

Ability to receive SMS text-messages

Exclusion Criteria

Not meeting inclusion criteria

Not being able to verify identification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive health-related messages in 5-7 online modules over 20-30 days, along with text-message health information

4-5 weeks

Online modules and text messages

Post-Intervention Assessment

Participants report on the usability and acceptability of the material, and both groups report on drinking and drinking-related consequences

1 week

Follow-up

Participants are monitored for secondary outcomes, including alcohol consumption and related consequences

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized feedback

Trial Overview The study tests personalized feedback through online modules and text messages aimed at improving drinking outcomes. Participants will either receive this intervention over a month or just undergo assessments without the additional health-related messages.

How Is the Trial Designed?

Group I: D3 online health information and text-messages Experimental Treatment 1 Intervention

Participants receiver personalized health information feedback across 5-7 online modules over 20-30 days along with text-message health information

Group II: Assessment only control Active Control 1 Intervention

Participants will receive questionnaires similar to intervention group but will not receive any health information modules or related text-messages

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+

Citations

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

Effectiveness of a Feedback-Based Brief Intervention to ... Results indicated that personalized feedback delivered no benefit beyond that of pre-treatment assessment procedures (phone screening and intake interview) ...

2. ajpmonline.org ajpmonline.org/article/S0749-3797(08)00968-9/fulltext

Curbing Problem Drinking with Personalized-Feedback ... The effectiveness of personalized-feedback interventions to reduce problem drinking has been evaluated in several RCTs and systematic reviews.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423000340

Evaluation of an integrated personalized feedback ... AP-PFI is designed to provide feedback about alcohol use, PTSD symptoms, and AS and their interplay and deliver psychoeducation on harm-reduction techniques.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/dar.13848

Effectiveness of web‐based personalised feedback ... The meta-analysis evidences the effectiveness of web-PFI for addressing university students' alcohol use, decreasing by 1.65 and 1.54 drinks consumed per week.

5. jmir.org jmir.org/2013/7/e137/

The Effectiveness of a Web-Based Personalized Feedback ... Unitcheck provides immediate, fully automated, personalized feedback on alcohol consumption and social norms information. This feedback was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4948182/

Personalized Feedback Interventions for College Alcohol ... Personalized drinking feedback is an evidence-based and increasingly common way of intervening with high-risk college drinking.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03337438?cond=%22Alcohol%20Drinking%22&viewType=Table&rank=4

NCT03337438 | Alcohol and Health: Personalized Feedback A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871621003082

A measure of illness awareness in alcohol use disorder ... The AAS is a novel instrument developed to measure impaired illness awareness in individuals with alcohol use disorder.

9. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions

Unhealthy Alcohol Use in Adolescents and Adults ... The USPSTF found adequate evidence that brief behavioral counseling interventions in adults who screen positive are associated with reduced unhealthy alcohol ...