IMPROVE for Binge Drinking and Anxiety

(BUCKS Trial)

Overseen By Sarah Millisor Irvin, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Severe substance use disorder, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help college students who drink heavily and struggle with anxiety. It tests a new program called IMPROVE, which targets anxiety and uncertainty to reduce stress and alcohol use. Participants will receive either the IMPROVE program or a general health education treatment. The trial seeks college students who drink heavily each week and feel stressed or anxious. Participants must use a smartphone to report their experiences during the trial.

As an unphased trial, this study offers a unique opportunity for students to access innovative support for managing anxiety and alcohol use.

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 is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that techniques for managing emotions, like those in the IMPROVE program, can lead to positive outcomes for people with substance use issues. Some studies have found that these methods help individuals control their emotions better, potentially resulting in less drinking and healthier habits.

While specific safety data for the IMPROVE program is not available, the techniques it employs are generally considered safe. Programs focusing on managing emotions and stress, such as mindfulness, have proven beneficial for people with alcohol use problems and mental health issues. These methods are usually safe because they don't involve medication or medical procedures. Instead, they help people change their thinking about stress and anxiety, which can reduce the urge to drink.

In summary, although direct safety data for IMPROVE is lacking, similar approaches are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for binge drinking and anxiety focus on medication or general counseling, but the IMPROVE protocol offers something new. It targets anxiety and uncertainty directly through a clinician-delivered approach, which is different from the broader healthy living advice given in many current programs. Researchers are excited because IMPROVE could provide more specific and effective support for individuals struggling with overwhelming emotions, potentially leading to better outcomes for both binge drinking and anxiety.

What evidence suggests that the IMPROVE intervention could be effective for binge drinking and anxiety?

Studies have shown that managing emotions can significantly reduce alcohol cravings and improve emotional well-being. Research indicates that programs focusing on emotion management often help people better control anxiety and depression. This is important because anxiety and uncertainty can lead to binge drinking. In this trial, participants in one arm will receive the IMPROVE intervention, which addresses these issues by teaching stress and emotion management. Previous findings suggest that better emotion management not only enhances mental health but also reduces substance use, including alcohol. Therefore, IMPROVE might help those dealing with binge drinking and anxiety. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for undergraduate students who often drink a lot and feel anxious. They should be willing to use their phones for daily surveys about their drinking habits. People can't join if they have certain conditions that might interfere with the study or if they're not able to follow the study procedures.

Inclusion Criteria

Report elevated psychological distress (i.e., Kessler Psychological Distress Scale scores >12)

Engage in heavy drinking behaviors (i.e., 15 drinks per week for biological males and 8 drinks per week for biological females)

Can read and comprehend English

Exclusion Criteria

Current comorbid moderate to severe substance use disorder other than nicotine

I am able to understand and consent to the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the IMPROVE intervention targeting anxiety and uncertainty or the Health Education Treatment (HET) focusing on healthy living

4-6 weeks

Weekly sessions (in-person or virtual)

Post-Intervention Assessment

Participants complete assessments to evaluate client satisfaction, system usability, and changes in anxiety sensitivity and intolerance of uncertainty

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in alcohol use, anxiety sensitivity, and resilience

1 month

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• IMPROVE

Trial Overview The trial tests IMPROVE, an intervention aimed at reducing anxiety and uncertainty by changing how students think about stress. It's compared against a general health promotion program (HET). Participants are randomly placed in one of these two groups and monitored through phone assessments.

How Is the Trial Designed?

Group I: Intervention Managing Psychological Responses to Overwhelming Emotions Experimental Treatment 1 Intervention

In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.

Group II: Health Education Treatment Active Control 1 Intervention

In this arm, participants will receive a clinician-delivered protocol with a digital component, called Health Education Treatment (HET). HET focuses on healthy living more broadly and does not include information about anxiety or uncertainty.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

The COMBINE Study successfully adapted the Systematic Assessment for Treatment Emergent Events (SAFTEE) to standardize the assessment of adverse events for naltrexone and acamprosate in treating alcohol dependence, ensuring consistent and reliable data collection.

The SAFTEE demonstrated high fidelity and flexibility in measuring adverse events across various settings, suggesting it could be a valuable tool for future clinical studies evaluating the safety and efficacy of new therapeutic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. Johnson, BA., Ait-Daoud, N., Roache, JD.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8275688/

Emotional processes in binge drinking: A systematic review ... Binge drinking is related to heightened negative emotional states, including greater severity of depressive and anxiety symptoms, and have difficulties in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10087816/

Emotion regulation in substance use disorders: a systematic ... For example, dialectical behavior therapy skills training not only improves emotion regulation but also increases rates of abstinence and decreases substance ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0005796724000548?dgcid=rss_sd_all

Brief emotion regulation strategies to reduce alcohol craving This study experimentally compared the effects of emotion regulation (ER) strategies on alcohol craving and examined the mediating effect of state ...

4. link.springer.com link.springer.com/article/10.1007/s10899-024-10366-8

Emotional Regulation in Substance-Related and Addictive ... The primary objective of this systematic review is to gather literature related to emotion regulation in psychological addictive disorders treatments.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000234

A systematic review of interventions aimed at improving ... The Emotion Regulation group showed greater improvement in rates of depression, anxiety and health-related quality of life which were maintained at follow up.

6. samhsa.gov samhsa.gov/libraries/evidence-based-practices-resource-center

Evidence-Based Practices Resource Center This document evaluates states' use of best practices in preventing underage drinking, as required by the STOP Act.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6883141/

Prevention, screening, and treatment for heavy drinking and ... There is also some evidence that mindfulness-based interventions are useful for individuals with AUD and comorbid mental health conditions. In ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S169726002400067X

Emotional dysregulation in relation to substance use and ... This meta-analysis examines the relationship between ED and ABs (alcohol, tobacco, cannabis, gambling, and gaming), and indicators of AB engagement.

9. medrxiv.org medrxiv.org/content/10.1101/2025.03.04.25323343v1.full-text

From Binge Drinking to Future Alcohol Severity This study examines how emotion regulation mediates the link between BD and future alcohol severity over two years in young people without prior alcohol use ...