Stress Management for College Students

Virtual Intervention Targeting Distress in College Students: a Pilot Study

The goal of this clinical trial is to learn if a virtual task can reduce distress in college students. The main questions it aims to answer are:

1. Will those who complete the virtual task have less distress?
2. Will men and women both benefit equally from the virtual task?

Researchers will compare the virtual task to a control task (another virtual task that we expect will not impact distress) to see if distress differs.

Participants will spend 20 minutes engaging in the virtual task (or the control task) on 3 different days all within one week. They will complete a survey about their well-being before starting the first virtual task and again ~6 weeks afterward.

Study Overview

• Status: Recruiting
• Conditions: Distress, Emotional
• Intervention / Treatment: Behavioral: Virtual Sequential Emotional Processing Task; Behavioral: Virtual Control Task

Detailed Description

Easily accessible and cost effective strategies for reducing emotional distress and improving stress tolerance in college students and the population generally are desired. The scalability and feasibility of virtual interventions hold promise for reaching segments of the population that find one-on-one psychotherapy aversive. Males in particular have higher perceived treatment stigma relative to women and find may typical traditional therapeutic processes incongruent with their masculine identity and values. The research team has designed an innovative, self-directed, virtual intervention to reduce distress and stress intolerance. The intervention consists of a set of virtual tasks which reflect the Sequential Model of Emotional Processing presented with language, imagery and content that engages men.

Using a randomized clinical trials design, this pilot project will compare the effects of the virtual intervention with a virtual control task on emotional well-being outcomes in college students.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Genuchi, PhD; Phone Number: 208-426-1207; Email: matthewgenuchi@boisestate.edu

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83709
      • Recruiting
      • Boise State University
      • Contact: Cindy McCrea, Ph.D.; Phone Number: 208-426-1207; Email: cindymccrea@boisestate.edu
      • Contact: Matthew Genuchi, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older
• college student

Exclusion Criteria:

• Younger than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Intervention	Behavioral: Virtual Sequential Emotional Processing Task; A 20-minute interactive session delivered 3 times over a one week period.
Sham Comparator: Virtual Control	Behavioral: Virtual Control Task; A time-matched (ie., 20 minute) interactive session delivered 3 times over a one week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Patient Health Questionnaire-2 (PHQ-2) scores to 6wks post intervention	The scale ranges from 0-6 where higher scores indicate more dysfunction.	From enrollment to the end of the ~6wk follow up period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Generalized Anxiety Disorder-2 scores to 6wks post intervention	The scale ranges from 0-6 where higher scores indicate more dysfunction.	From enrollment to the end of the ~6wk follow up period.
Change from baseline Connor-Davidson Resilience Scale-2 scores to 6wks post intervention	Possible scores range from 0-10 where higher scores indicate higher resilience.	From enrollment to the end of the ~6wk follow up period.

Collaborators and Investigators

• Sponsor: Boise State University
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): February 18, 2026
• Study Completion (Estimated): February 18, 2026

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: college students; virtual intervention; emotional distress; men/male
• Other Study ID Numbers: IRB24-765; U01GM152530 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No