Distress, EmotionalNCT06888141
Stress Management for College Students
A study testing Virtual Sequential Emotional Processing Task in people with Distress, Emotional, run by Boise State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distress, Emotional
- What is being tested?
- Virtual Sequential Emotional Processing Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- college student
Who cannot join
- Younger than 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boise State University
Boise, Idaho, 83709
Cindy McCrea, Ph.D., 208-426-1207, cindymccrea@boisestate.edu
Matthew Genuchi, Ph.D.
About this study
Official title: 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:
- Will those who complete the virtual task have less distress?
- 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.
Read the 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.
- Conditions
- Distress, Emotional
- Being tested
- Virtual Sequential Emotional Processing Task, Virtual Control Task
- Keywords
- virtual intervention, men/male, college students, emotional distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Sequential Emotional Processing TaskBehavioural
A 20-minute interactive session delivered 3 times over a one week period.
Virtual Control TaskBehavioural
A time-matched (ie., 20 minute) interactive session delivered 3 times over a one week period.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Intervention | Experimental | Not described Receives: Behavioral: Virtual Sequential Emotional Processing Task |
| Virtual Control | Sham comparator | Not described Receives: Behavioral: Virtual Control Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The scale ranges from 0-6 where higher scores indicate more dysfunction.
Measured: 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.
Measured: From enrollment to the end of the ~6wk follow up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start18 Feb 2025
- Primary completion18 Feb 2026 (estimated)
- Study completion18 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boise State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Matt Genuchi, Boise State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888141
- Sponsor's protocol ID
- IRB24-765
- Other IDs
- U01GM152530
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Intervention Targeting Distress in College Students: A Pilot Study
- ClinicalTrials.gov ID
- NCT06888141
- Acronym / sponsor ID
- IRB24-765
- Conditions
- Distress, Emotional
- Keywords
- virtual intervention, men/male, college students, emotional distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Boise State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 18 Feb 2026 (estimated)
- Study completion
- 18 Feb 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will those who complete the virtual task have less distress?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Intervention | Experimental | Behavioral: Virtual Sequential Emotional Processing Task |
| Virtual Control | Sham comparator | Behavioral: Virtual Control Task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- college student
Key exclusion criteria (1 listed)
- Younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Sequential Emotional Processing TaskA 20-minute interactive session delivered 3 times over a one week period. | Behavioural | Virtual Intervention |
| Virtual Control TaskA time-matched (ie., 20 minute) interactive session delivered 3 times over a one week period. | Behavioural | Virtual Control |
Primary outcome
Change from baseline Patient Health Questionnaire-2 (PHQ-2) scores to 6wks post intervention
Time frame: From enrollment to the end of the ~6wk follow up period.
The scale ranges from 0-6 where higher scores indicate more dysfunction.
2 secondary outcomes
Change from baseline Generalized Anxiety Disorder-2 scores to 6wks post intervention
Time frame: From enrollment to the end of the ~6wk follow up period.
Change from baseline Connor-Davidson Resilience Scale-2 scores to 6wks post intervention
Time frame: From enrollment to the end of the ~6wk follow up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Distress, Emotional
Recruiting
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
Anxiety, Depression
Not yet recruiting
A Randomized Controlled Trial of Group Psychological Intervention to Reduce Burnout Among Nursing Undergraduates
Psychological Distress Among Undergraduate Students
RecruitingPhase 2
Duloxetine in Inflammatory Bowel Diseases
Inflammatory Bowel Diseases
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Sequential Emotional Processing Task in people with Distress, Emotional, run by Boise State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Genuchi, PhD (208-426-1207, matthewgenuchi@boisestate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Patient Health Questionnaire-2 (PHQ-2) scores to 6wks post intervention (time frame: From enrollment to the end of the ~6wk follow up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.