Anxiety & Depression Association of America

Building Undergraduate Coping & Knowledge for Stress-Resilience

Purpose

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).

Conditions

Alcohol Use
College Drinking
Anxiety

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive one of two possible interventions.
Primary Purpose: Prevention
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.

Arm Groups

Arm	Description	Assigned Intervention
Experimental IMPROVE	In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.	Behavioral: IMPROVE 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
Active Comparator HET	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.	Behavioral: HET 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Ohio State University

Study Contact

Nicholas Allan, PhD
614-814-1299
nicholas.allan@osumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.