Building Undergraduate Coping & Knowledge for Stress-Resilience

NCT06885320 | Completed

• 1 other identifier: 2024H0393
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use; College Drinking; Anxiety

Keywords

alcohol; transdiagnostic; anxiety; college students

Outcome Measures

Primary Outcomes (8)

• Client Satisfaction Questionnaire-8

  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.

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

• System Usability Scale

  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.

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

• Intolerance of Uncertainty-12 Scale

  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.

  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-3 Scale

  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.

  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.

• Connor-Davidson Resilience Scale 10

  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.

  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.

• Timeline Followback

  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.

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

• Drinking Behaviors

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

  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.

• The Alcohol Use Disorders Identification Test

  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.

  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.

Study Arms (2)

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.

Behavioral: IMPROVE

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.

Behavioral: HET

Interventions

IMPROVE BEHAVIORAL

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

Intervention Managing Psychological Responses to Overwhelming Emotions

HET BEHAVIORAL

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.

Health Education Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcohol Drinking in College; Anxiety Disorders

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to receive one of two possible interventions.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 20, 2025
• Study Start: February 1, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for at least the next two years. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)