~27 spots leftby Jan 2027

IMPROVE for Binge Drinking and Anxiety

(BUCKS Trial)

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
No Placebo Group

Trial Summary

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).

Eligibility Criteria

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
+2 more

Exclusion Criteria

Current comorbid moderate to severe substance use disorder other than nicotine
I am able to understand and consent to the trial.

Participant Groups

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.
2Treatment groups
Experimental Treatment
Active Control
Group I: IMPROVEExperimental Treatment1 Intervention
In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.
Group II: HETActive Control1 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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
The Ohio State University Department of Psychiatry and Behavioral HealthColumbus, OH
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Who Is Running the Clinical Trial?

Ohio State UniversityLead Sponsor

References