Clinical trial NCT06888141: Stress Management for College Students
Official title: Virtual Intervention Targeting Distress in College Students: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distress, Emotional
Keywords: virtual intervention
men/male
college students
emotional distress
Lead sponsor: Boise State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-03-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* college student

Exclusion Criteria:

* Younger than 18 years of age

Primary outcomes:
measure: Change from baseline Patient Health Questionnaire-2 (PHQ-2) scores to 6wks post intervention
timeFrame: From enrollment to the end of the ~6wk follow up period.
Secondary outcomes:
measure: Change from baseline Generalized Anxiety Disorder-2 scores to 6wks post intervention
timeFrame: From enrollment to the end of the ~6wk follow up period.
measure: Change from baseline Connor-Davidson Resilience Scale-2 scores to 6wks post intervention
timeFrame: From enrollment to the end of the ~6wk follow up period.
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise State University
state: Idaho
Study officials:
References: