NCT06888141

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 6, 2025

Last Update Submit

March 14, 2025

Conditions

Distress, Emotional

Keywords

virtual interventionmen/malecollege studentsemotional distress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline Generalized Anxiety Disorder-2 scores to 6wks post intervention

    From enrollment to the end of the ~6wk follow up period.

  • Change from baseline Connor-Davidson Resilience Scale-2 scores to 6wks post intervention

    From enrollment to the end of the ~6wk follow up period.

Study Arms (2)

Virtual Intervention

EXPERIMENTAL
Behavioral: Virtual Sequential Emotional Processing Task

Virtual Control

SHAM COMPARATOR
Behavioral: Virtual Control Task

Interventions

Virtual Sequential Emotional Processing TaskBEHAVIORAL

A 20-minute interactive session delivered 3 times over a one week period.

Virtual Intervention
Virtual Control TaskBEHAVIORAL

A time-matched (ie., 20 minute) interactive session delivered 3 times over a one week period.

Virtual Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • college student

You may not qualify if:

  • Younger than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boise State University

Boise, Idaho, 83709, United States

RECRUITING

Central Study Contacts

Matthew Genuchi, PhD

CONTACT

208-426-1207matthewgenuchi@boisestate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 21, 2025

Study Start

February 18, 2025

Primary Completion

February 18, 2026

Study Completion

February 18, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)