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NCT05602779 · ClinicalTrials.gov registry record · NA
Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
A NA study of Suicidal Ideation and Self Harm, sponsored by University of Notre Dame.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT05602779: Recruiting NA study of Suicidal Ideation and Self Harm, sponsored by University of Notre Dame.
NCT05602779 is a NA study of Suicidal Ideation and Self Harm that is actively recruiting participants, run by University of Notre Dame. The registered enrollment target is 200 participants, below the 266-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (25% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05602779, a NA study of Suicidal Ideation and Self Harm, is actively recruiting participants, sponsored by University of Notre Dame.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study Summary
Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence. Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents' digital preferences. We will evaluate two unconventional but promising interventions delivered to 13- to 17-year-olds: transcutaneous vagus nerve stimulation to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. If effective, these digitally-delivered interventions could reach far more adolescents at far lower cost than current approaches.
Primary Outcome
Teens will be assessed at baseline visits for self-injurious thoughts and behaviors (non-suicidal self-injury (NSSI), suicidal ideation (SI), suicide attempts (SA)). They will complete measures individually on the Qualtrics Survey (SIQ) as well as participate in a face-to-face interview with a trained staff member to assess their level of NSSI, SI, and SA (CSSRS, DSHI). All participants will repeat these tasks at all visits (post-treatment, one-year follow-up). We expect teens who have used the
Conditions Studied
Interventions
- DEVICE tVNS Program
- OTHER Phone App Program
- COMBINATION_PRODUCT tVNS and Phone App Program
- OTHER Sham tNVS and Control App
Study Locations (2)
Indiana
- University of Notre Dame - South Bend
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-11-15 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
What NCT05602779 shows while recruiting
NCT05602779 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 266-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Suicidal Ideation appearing as the primary indexed condition, and to 4 interventions - of which tVNS Program is the first listed.
NCT05602779 reports a single indexed study location in Indiana, New York.
Frequently Asked Questions
What is clinical trial NCT05602779 about?
NCT05602779 is a clinical study titled "Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents". Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence. Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents' digital preferences. We will evaluate two unconventional but promising int...
What is the current status of trial NCT05602779?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-11-15. Estimated completion is 2027-09-30.
What conditions does trial NCT05602779 study?
This clinical trial studies the following conditions: Suicidal Ideation, Self Harm.
What interventions are being tested in trial NCT05602779?
The interventions under investigation include: tVNS Program (DEVICE), Phone App Program (OTHER), tVNS and Phone App Program (COMBINATION_PRODUCT), Sham tNVS and Control App (OTHER).
Who is sponsoring clinical trial NCT05602779?
This trial is sponsored by University of Notre Dame, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05602779 being conducted?
This trial has 2 study locations across Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05602779's enrollment target sits among peer trials
200 25th of 84 higher than 57 of 84 other Suicidal Ideation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicidal Ideation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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