- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885320
Building Undergraduate Coping & Knowledge for Stress-Resilience (BUCKS)
A Resilience-Based Intervention for Reducing Problematic Alcohol Use in College Populations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SIGNIFICANCE AND BACKGROUND A.1. What is the overarching problem? Heavy alcohol use is prevalent on college campuses across the US. According to recent data, nearly 60% of college students use alcohol, and 30% binge drink monthly (NSDUH, 2022). These rates are alarming given that heavy alcohol use is associated with academic difficulties, injuries, violence, suicide, risky sexual behaviors, and chronic and infectious diseases (CDC, 2021). Each year, over 1,500 college students die from alcohol-related unintentional injuries. The risky drinking patterns that are developed during college can persist for years after graduation (Arria et al., 2016). Although a mixture of prevention and intervention efforts have been adopted by universities to lower college drinking rates, heavy alcohol use in students has remained relatively stable over the past decade. Novel, innovative approaches are urgently needed to ameliorate heavy drinking and associated harmful consequences on college campuses.
A.2. Stress and problematic drinking. Converging lines of research indicate that individual differences in stress responding connote risk for the development of alcohol use disorder (AUD) across the developmental spectrum. Broadly, chronic and acute stressors increase AUD risk, frequency of heavy drinking, and worsen treatment outcomes. In college students, stress is a robust proximal antecedent to alcohol use (Aldridge-Gerry et al., 2011; Park et al., 2002). Studies utilizing ecological momentary assessments (EMA) have demonstrated that students are more likely to drink alcohol on days they endorse more perceived stress (CITE). Meanwhile, in the laboratory, exposure to acute psychological stress increases single-session alcohol consumption (CITE).
These studies are notable because stress is incredibly common amongst undergraduates. Nearly 80% of college students report ongoing moderate stress and an additional 10-12% report severe stress (Saleh et al., 2017). Perceived stress is a risk factor for heavy drinking as well as a variety of other mental and physical health conditions (CITE). Managing stress is therefore critical to subjective and objective well-being.
A.3. How can we target stress? Stress is ubiquitous and it is nearly impossible to reduce stress exposure without structural changes at the family, community, and university levels. Therefore, stress itself may not be the most viable target for changing trajectories of problematic alcohol use. A more practical and effective strategy is to intervene on the cognitive individual difference factors that shape responses to perceived stress. Indeed, this concept forms the basis of the Catastrophizing, Anxiety, Negative Urgency, and Expectancy (CANUE) model of alcohol use16. CANUE is a testable framework that was developed by Ferguson and colleagues to facilitate the development of behavioral and psychological interventions that target the processes that contribute to stress-related substance use. CANUE recognizes that alcohol use is often motivated by distress because of alcohol's acute stress-dampening effects. As attempts to escape stress are acutely reinforced, they become entrenched and alcohol use emerges as a primary coping strategy17. These processes set the stage for the onset of AUD. What is unique about the CANUE model is that there are several modifiable individual difference factors that are theorized to play an important role in self-medicating perceived stress with alcohol.
Examples of theoretically relevant moderators include distress-related attitudes and beliefs such as anxiety sensitivity (AS) and intolerance of uncertainty (IU). AS is defined as the tendency to interpret anxiety-related bodily sensations as indicative of impending danger or harm33 whereas IU is the propensity to respond to uncertain events and situations negatively34. AS and IU are implicated early in the temporal unfolding of the stress-to-alcohol use chain of events and influence the intensity of the negative emotional state that stems from perceived distress. In other words, IU and AS are involved in amplifying the intensity of negative affect in response to stressful stimuli and independently and synergistically interact to drive the negative reinforcement processes underlying stress-related alcohol use and onset of AUD.
A.4. Resilience versus Risk. AS and IU develop early in life and are shaped by genetic, familial, and environmental influences. Most importantly, they significantly affect the long-term course of mental health symptoms. Longitudinal studies in adolescents and young adults have shown that both AS and IU predict increases in heavy drinking and onset of AUD diagnoses (DeMartini & Carey, 2011; MORE). In college students, specifically, both MPI Gorka and Allan have demonstrated that AS/IU influence subsequent alcohol use behaviors (Gorka et el., 2023; MORE). While AS and IU are often labeled as 'risk factors,' they are dimensional constructs that can range from adaptive to maladaptive. High levels of AS/IU may increase risk, whereas low levels may promote resilience. Resilience is a complex concept that represents an individual's capacity to cope with stress and overcome adversity. Effective stress management is central to the definition of resilience (Luthar et al., 2000). Accordingly, several existing resilience programs for youth focus on building coping strategies for managing acute stressors. These initial studies demonstrated that resilience training can lower perceived stress and improve mental health outcomes; however, enthusiasm for stress-focused resilience training has recently plateaued. This shift is driven by the modest effect sizes observed in early trials, concerns about the long-term sustainability of training-related benefits, and increasing awareness that many stress-focused resilience trainings lack a clear theoretical foundation.
A.5. How to optimize resilience programs for stress? To enhance the efficacy of resilience programs, it is essential to integrate a theoretically grounded approach that addresses the cognitive vulnerabilities associated with stress, such as AS and IU. By targeting these modifiable factors, interventions can be tailored to individuals' specific cognitive profiles, enhancing their capacity to manage stress effectively and reducing reliance on maladaptive coping mechanisms like alcohol use.
A6 Our pilot studies have utilized brief, modular CBT interventions targeting AS and IU, focusing on psychoeducation, cognitive restructuring, and exposure exercises. This approach has shown promise in modifying cognitive biases associated with stress-related alcohol use. Data-driven adjustments have enhanced treatment fidelity and effectiveness. Future work will refine and evaluate these strategies for heavy alcohol users in the current study.
A8 IMPROVE targets AS and IU using self-report and objective measures, including EEG and startle potentiation. These measures will assess intervention impact on stress and alcohol use. This study will be the first to compare changes in subjective and objective responses to a CBT-based intervention, informing future precision medicine approaches.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Department of Psychiatry and Behavioral Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
- age 18 or older
- can read and comprehend English
- has access to a smartphone
Exclusion Criteria:
- limited mental competency/inability to give informed consent
- current comorbid moderate to severe substance use disorder other than nicotine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Managing Psychological Responses to Overwhelming Emotions
In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.
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IMPROVE is an individual manualized intervention.
Session1 includes: • psychoeducation focusing on anxiety, its role in contributing to substance use, and the maintaining role of fear of bodily sensations • guided discussion of maladaptive thoughts about bodily sensations related to anxiety • how to challenge bodily sensations cognitively • generating three takeaways about the benign nature of anxiety Session 2 includes: • review of homework • psychoeducation focusing on the role of uncertainty in anxiety and identifying how new information can inform beliefs about uncertainty.
• when to challenge thoughts related to uncertainty and when to use acceptance regarding uncertainty.
Session 3 includes: • review interoceptive exposure (IE) and behavioral exercises (BE) for progress • revisit beliefs related to cognitive biases • discuss areas where skills can be used moving forward
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Active Comparator: Health Education Treatment
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.
|
Clinicians will administer HET using a PowerPoint presentation focused on healthy living habits, including healthy eating, water consumption, and sleep hygiene.
Clinicians will guide participants through an exercise using the USDA "food tracker" to plan, record, and monitor nutritional information of meals.
HET also includes a digital program that will include EDUCATION, MY CURRENT MOOD, and BEHAVIORAL ACTIVITY tabs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire-8
Time Frame: Week 4 (Day 28): administered immediately after the post-intervention laboratory visit, one week after Session 3.
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Client satisfaction is measured using the 8-item Client Satisfaction Questionnaire.
Each item is measured on a 4-point scale from (1) Poor to (4) Excellent.
Higher scores indicate greater satisfaction with scores ranging from 8 to 32.
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Week 4 (Day 28): administered immediately after the post-intervention laboratory visit, one week after Session 3.
|
|
System Usability Scale
Time Frame: Week 4 (Day 28): administered immediately after the post-intervention laboratory visit.
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Intervention usability is measured using the 10-item System Usability Scale.
Each item is measured on a 5-point scale from (1) Strongly Disagree to (5) Strongly Agree.
Higher scores indicate higher usability with scores ranging from 0 to 100.
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Week 4 (Day 28): administered immediately after the post-intervention laboratory visit.
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Intolerance of Uncertainty-12 Scale
Time Frame: Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Intolerance of uncertainty is measured using the 12-item Intolerance of Uncertainty Scale - Short Form.
Each item is measured on a 5-point scale from (1) Not At All Characteristic Of Me to (5) Entirely Characteristic Of Me.
Higher scores indicate worse intolerance of uncertainty with scores ranging from 12 to 60.
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Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Anxiety Sensitivity-3 Scale
Time Frame: Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Anxiety sensitivity is measured using the 18-item Anxiety Sensitivity Scale.
Each item is measured on a 5-point scale from (1) Very Little to (5) Very Much.
Higher scores indicate higher anxiety sensitivity with scores ranging from 18 to 90.
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Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Connor-Davidson Resilience Scale 10
Time Frame: Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Resilience is measured using the 10-item Connor-Davidson Resilience Scale.
Each item is measured on a 5-point scale from (0) Not True At All to (4) True Nearly All The Time.
Higher scores indicate greater resilience with scores ranging from 0 to 40.
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Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Timeline Followback
Time Frame: Baseline (Day 0) and Week 4 (Day 28): 30-day recall at each assessment; change calculated between the two administrations.
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Substance use is measured using The Timeline Followback (TLFB).
The TLFB asks participants to estimate their substance use 7 days to 2 years prior to the interview date.
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Baseline (Day 0) and Week 4 (Day 28): 30-day recall at each assessment; change calculated between the two administrations.
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Drinking Behaviors
Time Frame: Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Alcohol use is measured using the drinking behaviors questionnaire.
Participants are asked to report alcohol consumption over the past month.
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Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
|
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The Alcohol Use Disorders Identification Test
Time Frame: Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Alcohol use is measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT).
The AUDIT assesses alcohol consumption, drinking behaviors, and alcohol-related problems.
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Baseline (Day 0), Week 4 (Day 28), and Week 8 (Day 56): change scores will be calculated from Day 0 to each follow-up point.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024H0393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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