Technology Enhanced Adolescent Mental Health (TEAM)

Not Applicable

Recruiting

• Conditions: Nonsuicidal Self Injury; Alcohol Abuse; Vagus Nerve Stimulation
• Interventions: Device: No Intervention; Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)

• Registration Number: NCT05343039
• Lead Sponsor: University of Notre Dame

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, 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.

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-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.

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Study Start: 2022-09-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Treatment Group	No Intervention	Participants will not receive a tVNS device.
Treatment Group	Non-invasive Transcutaneous Nerve Stimulation (tVNS)	Participants will receive a tVNS device.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Emotion Regulation at Day 30	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.
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30	30 days	Participants will engage in 25-minute tVNS sessions daily.
Maintenance of Treatment Effects at 3 Months Post Intervention	3 months	Participants will be evaluated on the maintenance of any such treatment effects 3 months post intervention.

Secondary Outcome Measures

Name	Time	Method
Adherence to tVNS Intervention from Baseline to Day 30	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.

Trial Locations

Locations (1)

University of Notre Dame; 🇺🇸 South Bend, Indiana, United States