Technology Enhanced Adolescent Mental Health (TEAM)

Alcohol Abuse Clinical Trial

— TEAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05343039
• Other study ID #: 21-11-6898
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: University of Notre Dame
• Contact: Theodore P Beauchaine, PhD
• Phone: (574) 631-3910
• Email: tbeaucha[@]nd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Nonsuicidal Self Injury
• Self-Injurious Behavior
• Vagus Nerve Stimulation

Intervention

Device:
• Non-invasive Transcutaneous Nerve Stimulation (tVNS)
Participants will engage in 25-minute tVNS sessions every day for 30 days.
• No Intervention
Participants will not receive any intervention.

Locations

Country	Name	City	State
United States	University of Notre Dame	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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