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OpenTrials
Completed

NCT Number: NCT05343039

Technology Enhanced Adolescent Mental Health (TEAM)

Adolescent nonsuicidal self-injury (NSSI) and alcohol misuse, alone and especially in combination, portend significant functional impairment in adulthood (e.g., relationship dysfunction, depression, suicidality). Although psychosocial interventions for NSSI and substance use are effective for some, they are also expensive and require highly trained clinicians. Treatment is therefore often unavailable to disadvantaged adolescents and those who live rurally. Thus, lower-cost alternative treatments are needed. We will evaluate the efficacy of noninvasive transcutaneous vagus nerve stimulation (tVNS), an effective treatment for depression, in reducing risk for NSSI and substance misuse among vulnerable adolescents.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Notre Dame

South Bend, Indiana, 46617, United States

About this study

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-administered tVNS, delivered in 25-minute sessions, will reduce self-reported NSSI and alcohol use, improve adolescents' self-reported emotion regulation, and yield improvements in sympathetic and parasympathetic nervous system markers of emotion regulation and vulnerability to NSSI and alcohol misuse. AIM 2: Evaluate treatment adherence compared with traditional psychosocial interventions of similar duration. We hypothesize that adolescents will demonstrate greater treatment adherence than observed in traditional psychosocial interventions of similar duration, and rate tVNS as acceptable, unobtrusive, and favorable to face-to-face treatment. AIM 3: Evaluate maltreatment effects on tVNS. We hypothesize that tVNS will be effective for those with histories of maltreatment.

Although rarely used to date among adolescents, tVNS alters neural and emotional responses to sad stimuli, and among adults, reduces suicide risk up to five years later. At present, it is being evaluated as a treatment for alcohol misuse in a NIH-funded clinical trial. This suggests potential for treating NSSI, alcohol misuse, post-traumatic stress symptoms (PTSS), and other disorders of emotion dysregulation. As outlined above, we will test the efficacy of tVNS in altering behavioral, emotional, and autonomic nervous system risk for NSSI and alcohol misuse, evaluate adherence and acceptability of tVNS among adolescents, and determine if maltreatment histories moderate treatment response.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Non-invasive Transcutaneous Nerve Stimulation (tVNS)

Device

Participants will engage in 25-minute tVNS sessions every day for 30 days.

No Intervention

Device

Participants will not receive any intervention.

Primary outcomes

  1. Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30

    Time frame: 30 days

    Participants will engage in 25-minute tVNS sessions daily.

  2. Maintenance of Treatment Effects at 3 Months Post Intervention

    Time frame: 3 months

    Participants will be evaluated on the maintenance of any such treatment effects 3 months post intervention.

  3. Change from Baseline in Emotion Regulation at Day 30

    Time frame: 30 days

    Participants will complete a 2-3 minute survey daily in which they are to report on different feelings and emotions such as happiness, sadness, and anger.

Secondary outcomes

  1. Adherence to tVNS Intervention from Baseline to Day 30

    Time frame: 30 days

    Adherence of participants' self-administered daily 25-minute tVNS sessions will be measured from participants' tVNS phone app. They will also report on acceptability, obtrusiveness, and favorability of tVNS.

Sponsors and collaborators

Lead sponsor

University of Notre Dame

Other

Registry information

Official study title

Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents

Acronym: TEAM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2022
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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