Clinical trial NCT06885320: Building Undergraduate Coping & Knowledge for Stress-Resilience
Official title: A Resilience-Based Intervention for Reducing Problematic Alcohol Use in College Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
College Drinking
Anxiety
Keywords: alcohol
transdiagnostic
anxiety
college students
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive one of two possible interventions.
Primary purpose: PREVENTION

Brief summary: 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: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire-8
timeFrame: Scores will be assessed at the post-intervention session (approx. 1 week after completing the final intervention session)
measure: System Usability Scale
timeFrame: Scores will be assessed at the post-intervention session (approx. 1 week after completing the final intervention session)
measure: Intolerance of Uncertainty-12 Scale
timeFrame: Change will be assessed from baseline to a) the post-intervention session (approx. 1 week after completing the final intervention session) and b) 1-month follow-up
measure: Anxiety Sensitivity-3 Scale
timeFrame: Change will be assessed from baseline to a) the post-intervention session (approx. 1 week after completing the final intervention session) and b) 1-month follow-up
measure: Connor-Davidson Resilience Scale 10
timeFrame: Change will be assessed from baseline to a) the post-intervention session (approx. 1 week after completing the final intervention session) and b) 1-month follow-up
measure: Timeline Followback
timeFrame: Change will be assessed from baseline to the post-intervention session (approx. 1 week after completing the final intervention session)
measure: Drinking Behaviors
timeFrame: Change will be assessed from baseline to a) the post-intervention session (approx. 1 week after completing the final intervention session) and b) 1-month follow-up
measure: The Alcohol Use Disorders Identification Test
timeFrame: Change will be assessed from baseline to a) the post-intervention session (approx. 1 week after completing the final intervention session) and b) 1-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Department of Psychiatry and Behavioral Health
state: Ohio
Study officials:
References: