Status:
COMPLETED
Technology Enhanced Adolescent Mental Health (TEAM)
Lead Sponsor:
University of Notre Dame
Conditions:
Nonsuicidal Self Injury
Alcohol Abuse
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
Adolescent nonsuicidal self-injury (NSSI) and alcohol misuse, alone and especially in combination, portend significant functional impairment in adulthood (e.g., relationship dysfunction, depression, s...
Detailed Description
The overarching goals of the proposed project are threefold. AIM 1: Evaluate the clinical efficacy of tVNS in reducing NSSI and alcohol misuse among vulnerable adolescents. We hypothesize that self-ad...
Eligibility Criteria
Inclusion
- Have used alcohol
- Have engaged in ≥ 3 episodes of NSSI in the past 6 months or ≥ 5 lifetime (1 of these 5 must be in the past year)
- Own a smartphone (iPhone or Android)
Exclusion
- Autism
- Schizophrenia
- Have a cardiac pacemaker, implanted defibrillator, or implanted or metallic electronic device
- Pregnant or breastfeeding
- Have a history of seizures or epilepsy
- Temperomandibular Joint Disorder
- Bell's Palsy
- Impaired cranial nerve function or facial pain
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05343039
Start Date
September 6 2022
End Date
January 15 2025
Last Update
August 17 2025
Active Locations (1)
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1
University of Notre Dame
South Bend, Indiana, United States, 46617