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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Nearly 60% of college students use alcohol and 30% binge drink monthly. This is alarming given that heavy alcohol use is linked to serious detrimental outcomes. Despite various prevention and intervention strategies, heavy alcohol use has remained relatively stable over the past decade. Individual differences in stress response connote risk for alcohol use disorder. Anxiety sensitivity (AS) and intolerance of uncertainty (IU) are two key cognitive vulnerabilities that can hinder resilience by amplifying stress responses and promoting maladaptive coping strategies, such as alcohol use. Effective stress management is a cornerstone of resilience. The Intervention for Managing Psychological Responding to Overwhelming Emotions (IMPROVE) targets AS and IU, key barriers to resilience, by modifying cognitive processes that amplify stress and negative affect. In this study, undergraduate students who engage in heavy drinking behaviors and experience elevated anxiety symptoms will be randomized to IMPROVE or a control health promotion intervention (N=20 per arm). All participants will complete daily ecological momentary assessments (EMA) delivered to participants' mobile phones to capture real-world alcohol use before, during, and after the intervention. The investigators will evaluate the feasibility and acceptability of IMPROVE (Aim 1). The investigators will also include a multimodal battery of self-report and objective lab-based measures of AS and IU involving startle eyeblink potentiation and event-related potentials via electromyography (EMG) and electroencephalography (EEG). This will allow the investigators to examine whether IMPROVE changes IU and AS, and to assess if changes in these targets are associated with changes in alcohol use (Aim 2).

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.

What safety data exists for the treatment evaluated in the IMPROVE trial for binge drinking and anxiety?

The safety of treatments for alcohol dependence, like those in the IMPROVE trial, is monitored through adverse event reporting, but this process can sometimes be incomplete or inconsistent. In trials for alcohol use disorder, safety monitoring is a routine practice, but there is a need for more comprehensive tracking of all possible side effects, including those from behavioral interventions. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment IMPROVE for binge drinking and anxiety?

Research shows that treating anxiety in people with alcohol problems can help reduce relapse rates. Additionally, combining traditional treatment with new methods like approach bias modification (a type of training to change automatic responses) has been more effective for those with both anxiety and alcohol issues. ^{6 7 8 9 10}

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

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]

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]

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

Does comorbid anxiety or depression moderate effects of approach bias modification in the treatment of alcohol use disorders? [2022]

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

World Health Organization (WHO) risk level reductions in inpatients with alcohol use disorder and comorbid anxiety disorders. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of alcohol use severity on anxiety treatment outcomes in a large effectiveness trial in primary care. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[The effectiveness of anxiety treatment on alcohol-dependent patients with a comorbid phobic disorder: a randomised controlled trial]. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Management of co-morbid anxiety and alcohol disorders: parallel treatment of disorders. [2005]

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

Strategies for safety reporting in substance abuse trials. [2013]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

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

Rates of discontinuation and non-publication of trials for the pharmacologic treatment of alcohol use disorder. [2022]

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

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. [2019]

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

Comparison of healthcare utilization among patients treated with alcoholism medications. [2021]