跳至主要内容
临床试验/NCT06885320
NCT06885320已完成不适用

A Resilience-Based Intervention for Reducing Problematic Alcohol Use in College Populations

Ohio State University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Client Satisfaction Questionnaire-8

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Raters completing the outcome assessments will be blind to condition. Participants are told they are receiving an intervention to help cope with distress but not which of the two interventions is the active and which is the control.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •limited mental competency/inability to give informed consent
  • •current comorbid moderate to severe substance use disorder other than nicotine

研究组 & 干预措施

Intervention Managing Psychological Responses to Overwhelming Emotions

Experimental

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

干预措施: IMPROVE (Behavioral)

Health Education Treatment

Active Comparator

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.

干预措施: HET (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire-8

时间窗: Week 4 (Day 28): administered immediately after the post-intervention laboratory visit, one week after Session 3.

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.

System Usability Scale

时间窗: Week 4 (Day 28): administered immediately after the post-intervention laboratory visit.

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.

Intolerance of Uncertainty-12 Scale

时间窗: 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.

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.

Anxiety Sensitivity-3 Scale

时间窗: 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.

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.

Connor-Davidson Resilience Scale 10

时间窗: 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.

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.

Timeline Followback

时间窗: Baseline (Day 0) and Week 4 (Day 28): 30-day recall at each assessment; change calculated between the two administrations.

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.

Drinking Behaviors

时间窗: 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.

Alcohol use is measured using the drinking behaviors questionnaire. Participants are asked to report alcohol consumption over the past month.

The Alcohol Use Disorders Identification Test

时间窗: 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.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Allan

Assistant Professor

Ohio State University

研究点 (1)

Loading locations...

相似试验