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Technology Enhanced Adolescent Mental Health (TEAM)

NCT05343039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-17

No results posted yet for this study

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, 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.

Conditions

  • Nonsuicidal Self Injury
  • Alcohol Abuse
  • Vagus Nerve Stimulation

Interventions

DEVICE

Non-invasive Transcutaneous Nerve Stimulation (tVNS)

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

DEVICE

No Intervention

Participants will not receive any intervention.

Sponsors & Collaborators

  • University of Notre Dame

    lead OTHER

Principal Investigators

  • Theodore P Beauchaine, PhD · University of Notre Dame

  • Brooke A Ammerman, PhD · University of Notre Dame

  • Kristin Valentino, PhD · University of Notre Dame

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2025-01-15
Completion
2025-01-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343039 on ClinicalTrials.gov