Technology Enhanced Adolescent Mental Health (TEAM)

University of Notre Dame

Status: Enrolling

Conditions: Nonsuicidal Self Injury; Vagus Nerve Stimulation; Alcohol Abuse

Treatments: Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS); Device: No Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05343039

21-11-6898

Details and patient eligibility

About

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.

Full 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-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.

Enrollment: 50 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Participants will receive a tVNS device.

Treatment:

Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)

Non-Treatment Group

Experimental group

Description:

Participants will not receive a tVNS device.

Treatment:

Device: No Intervention