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Technology Enhanced Adolescent Mental Health (TEAM)

Sponsor
University of Notre Dame (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05343039
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
32.1
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)
  • Device: No Intervention
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Participants will receive a tVNS device.

Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)
Participants will engage in 25-minute tVNS sessions every day for 30 days.
Experimental: Non-Treatment Group

Participants will not receive a tVNS device.

Device: No Intervention
Participants will not receive any intervention.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Notre Dame South Bend Indiana United States 46617

Sponsors and Collaborators

  • University of Notre Dame

Investigators

  • Principal Investigator: Theodore P Beauchaine, PhD, University of Notre Dame
  • Principal Investigator: Brooke A Ammerman, PhD, University of Notre Dame
  • Principal Investigator: Kristin Valentino, PhD, University of Notre Dame

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Notre Dame
ClinicalTrials.gov Identifier:
NCT05343039
Other Study ID Numbers:
  • 21-11-6898
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Notre Dame
Adolescence
Emotion Regulation
Additional relevant MeSH terms:
Alcoholism
Self-Injurious Behavior

Study Results

No Results Posted as of Apr 25, 2022