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Not Yet Recruiting
NCT05602779
Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
Conditions: Self Harm, Suicidal Ideation
Sex: All
Ages: 13 Years – 17 Years
Phase: NA
Enrollment: 212
Sponsor: University of Notre Dame
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.
Eligibility Criteria
Inclusion Criteria:Aged between 13 and 17 years,Attend in person meetings in South Bend, IN or Rochester, NY. and,Two of the following which will be scored during the phone screen:Engaged in non-suicidal self-harm 3 times in the past 6 months or more than 5 times in their life time, with one occurrence in the past year.Show high scores on emotional dysregulationShow high scores on social isolationShow high scores on impulsivityShow high scores on depressionEngage in alcohol or other substance useExclusion Criteria:Parent reported autism or schizophreniaImplanted pacemaker or cardiac defibrillator, other implanted or metallic devicePregnant or breast feedingHistory of seizures or epilepsyTMJ DisorderBells' PalsyImpaired cranial nerve functionFacial Pain
Source: ClinicalTrials.gov (NCT05602779). StuddyBuddy aggregates publicly available trial information.