Technology Enhanced Adolescent Mental Health (TEAM)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nonsuicidal Self Injury, Alcohol Abuse, Vagus Nerve Stimulation

Intervention / Treatment
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* Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)
* Device: No Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Participants will receive a tVNS device. | Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)<br>* Participants will engage in 25-minute tVNS sessions every day for 30 days.<br>|
| Experimental: Non-Treatment Group<br>Participants will not receive a tVNS device. | Device: No Intervention<br>* Participants will not receive any intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to tVNS Intervention from Baseline to Day 30 | 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescence, Emotion Regulation