Nonsuicidal Self InjuryTEAMNCT05343039
Technology Enhanced Adolescent Mental Health (TEAM)
A study testing Non-invasive Transcutaneous Nerve Stimulation (tVNS) in people with Nonsuicidal Self Injury and Alcohol Abuse, run by University of Notre Dame at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonsuicidal Self Injury, Alcohol Abuse, Vagus Nerve Stimulation
- What is being tested?
- Non-invasive Transcutaneous Nerve Stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents
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.
Read the 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.
- Being tested
- Non-invasive Transcutaneous Nerve Stimulation (tVNS), No Intervention
- Keywords
- Adolescence, Emotion Regulation
- Medical subject headings
- Self-Injurious Behavior, Alcoholism, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Transcutaneous Nerve Stimulation (tVNS)Device
Participants will engage in 25-minute tVNS sessions every day for 30 days.
No InterventionDevice
Participants will not receive any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants will receive a tVNS device. Receives: Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS) |
| Non-Treatment Group | Experimental | Participants will not receive a tVNS device. Receives: Device: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30
Participants will engage in 25-minute tVNS sessions daily.
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start6 Sep 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (118)Papers the sponsor has linked to this study.
- Other trials for Nonsuicidal Self InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore P Beauchaine, PhD, Principal investigator, University of Notre DameBrooke A Ammerman, PhD, Principal investigator, University of Notre DameKristin Valentino, PhD, Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343039
- Sponsor's protocol ID
- 21-11-6898
- Acronym
- TEAM
- Status last verified
- Aug 2025
- First submitted
- 11 Apr 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaronson ST, Sears P, Ruvuna F, Bunker M, Conway CR, Dougherty DD, Reimherr FW, Schwartz TL, Zajecka JM. A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality. Am J Psychiatry. 2017 Jul 1;174(7):640-648. doi: 10.1176/appi.ajp.2017.16010034. Epub 2017 Mar 31.
PubMed 28359201Achenbach, T.M. (1991). Manual for the youth self-report and 1991 profile. Burlington, VT: University of Vermont Department of Psychiatry.
American Foundation for Suicide Prevention. (2021). Project 2025: A nationwide initiative to reduce the annual rate of suicide in the U.S. by 20 percent by 2025. Retrieved on 6/23/2021 from https://project2025.afsp.org/
Anestis MD, Pennings SM, Lavender JM, Tull MT, Gratz KL. Low distress tolerance as an indirect risk factor for suicidal behavior: considering the explanatory role of non-suicidal self-injury. Compr Psychiatry. 2013 Oct;54(7):996-1002. doi: 10.1016/j.comppsych.2013.04.005. Epub 2013 May 16.
PubMed 23684548Beauchaine T. Vagal tone, development, and Gray's motivational theory: toward an integrated model of autonomic nervous system functioning in psychopathology. Dev Psychopathol. 2001 Spring;13(2):183-214. doi: 10.1017/s0954579401002012.
PubMed 11393643Beauchaine TP. Future Directions in Emotion Dysregulation and Youth Psychopathology. J Clin Child Adolesc Psychol. 2015;44(5):875-96. doi: 10.1080/15374416.2015.1038827. Epub 2015 May 27.
PubMed 26016727Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11.
PubMed 26272488Beauchaine TP, Cicchetti D. Emotion dysregulation and emerging psychopathology: A transdiagnostic, transdisciplinary perspective. Dev Psychopathol. 2019 Aug;31(3):799-804. doi: 10.1017/S0954579419000671. No abstract available.
PubMed 31290735Beauchaine TP, Hinshaw SP, Bridge JA. Nonsuicidal Self-Injury and Suicidal Behaviors in Girls: The Case for Targeted Prevention in Preadolescence. Clin Psychol Sci. 2019 Jul;7(4):643-667. doi: 10.1177/2167702618818474. Epub 2019 Jan 28.
PubMed 31485384Beauchaine TP, Bell Z, Knapton E, McDonough-Caplan H, Shader T, Zisner A. Respiratory sinus arrhythmia reactivity across empirically based structural dimensions of psychopathology: A meta-analysis. Psychophysiology. 2019 May;56(5):e13329. doi: 10.1111/psyp.13329. Epub 2019 Jan 23.
PubMed 30672603Beauchaine TP, Sauder CL, Derbidge CM, Uyeji LL. Self-injuring adolescent girls exhibit insular cortex volumetric abnormalities that are similar to those seen in adults with borderline personality disorder. Dev Psychopathol. 2019 Oct;31(4):1203-1212. doi: 10.1017/S0954579418000822.
PubMed 30394252Beauchaine, T. P., & Crowell, S. E. (Eds.) (2020). The Oxford handbook of emotion dysregulation. NY: Oxford University Press.
Behavioral Tech. (2021). DBT training and certification. Retrieved on 6/23/2021 from https://behavioraltech.org/re sources/faqs/training-faqs/
Bell Z, Shader T, Webster-Stratton C, Reid MJ, Beauchaine TP. Improvements in Negative Parenting Mediate Changes in Children's Autonomic Responding Following a Preschool Intervention for ADHD. Clin Psychol Sci. 2018;6(1):134-144. doi: 10.1177/2167702617727559. Epub 2017 Sep 26.
PubMed 29545976Berman, A. H., Bergman, H., Palmstierna, T., & Schlyter, F. (2002). Drug use disorders identification test. https://www.emcdda.europa.eu/system/files/attachments/12173/DUDIT-English-version.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents
- ClinicalTrials.gov ID
- NCT05343039
- Acronym / sponsor ID
- TEAM / 21-11-6898
- Keywords
- Adolescence, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Non-invasive Transcutaneous Nerve Stimulation (tVNS)Participants will receive a tVNS device. |
| Non-Treatment Group | Experimental | Device: No InterventionParticipants will not receive a tVNS device. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- Autism
- Schizophrenia
- Have a cardiac pacemaker, implanted defibrillator, or implanted or metallic electronic device
- Pregnant or breastfeeding
- Have a history of seizures or epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Transcutaneous Nerve Stimulation (tVNS)Participants will engage in 25-minute tVNS sessions every day for 30 days. | Device | Treatment Group |
| No InterventionParticipants will not receive any intervention. | Device | Non-Treatment Group |
Primary outcome
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30
Time frame: 30 days
Participants will engage in 25-minute tVNS sessions daily.
Maintenance of Treatment Effects at 3 Months Post Intervention
Time frame: 3 months
Participants will be evaluated on the maintenance of any such treatment effects 3 months post intervention.
Change from Baseline in Emotion Regulation at Day 30
Time frame: 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.
1 secondary outcome
Adherence to tVNS Intervention from Baseline to Day 30
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 28359201Aaronson ST, Sears P, Ruvuna F, Bunker M, Conway CR, Dougherty DD, Reimherr FW, Schwartz TL, Zajecka JM. A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality. Am J Psychiatry. 2017 Jul 1;174(7):640-648. doi: 10.1176/appi.ajp.2017.16010034. Epub 2017 Mar 31.
- BackgroundAchenbach, T.M. (1991). Manual for the youth self-report and 1991 profile. Burlington, VT: University of Vermont Department of Psychiatry.
- BackgroundAmerican Foundation for Suicide Prevention. (2021). Project 2025: A nationwide initiative to reduce the annual rate of suicide in the U.S. by 20 percent by 2025. Retrieved on 6/23/2021 from https://project2025.afsp.org/
- Background: PubMed 23684548Anestis MD, Pennings SM, Lavender JM, Tull MT, Gratz KL. Low distress tolerance as an indirect risk factor for suicidal behavior: considering the explanatory role of non-suicidal self-injury. Compr Psychiatry. 2013 Oct;54(7):996-1002. doi: 10.1016/j.comppsych.2013.04.005. Epub 2013 May 16.
- Background: PubMed 11393643Beauchaine T. Vagal tone, development, and Gray's motivational theory: toward an integrated model of autonomic nervous system functioning in psychopathology. Dev Psychopathol. 2001 Spring;13(2):183-214. doi: 10.1017/s0954579401002012.
- Background: PubMed 26016727Beauchaine TP. Future Directions in Emotion Dysregulation and Youth Psychopathology. J Clin Child Adolesc Psychol. 2015;44(5):875-96. doi: 10.1080/15374416.2015.1038827. Epub 2015 May 27.
- Background: PubMed 26272488Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11.
- Background: PubMed 31290735Beauchaine TP, Cicchetti D. Emotion dysregulation and emerging psychopathology: A transdiagnostic, transdisciplinary perspective. Dev Psychopathol. 2019 Aug;31(3):799-804. doi: 10.1017/S0954579419000671. No abstract available.
- Background: PubMed 31485384Beauchaine TP, Hinshaw SP, Bridge JA. Nonsuicidal Self-Injury and Suicidal Behaviors in Girls: The Case for Targeted Prevention in Preadolescence. Clin Psychol Sci. 2019 Jul;7(4):643-667. doi: 10.1177/2167702618818474. Epub 2019 Jan 28.
- Background: PubMed 30672603Beauchaine TP, Bell Z, Knapton E, McDonough-Caplan H, Shader T, Zisner A. Respiratory sinus arrhythmia reactivity across empirically based structural dimensions of psychopathology: A meta-analysis. Psychophysiology. 2019 May;56(5):e13329. doi: 10.1111/psyp.13329. Epub 2019 Jan 23.
- Background: PubMed 30394252Beauchaine TP, Sauder CL, Derbidge CM, Uyeji LL. Self-injuring adolescent girls exhibit insular cortex volumetric abnormalities that are similar to those seen in adults with borderline personality disorder. Dev Psychopathol. 2019 Oct;31(4):1203-1212. doi: 10.1017/S0954579418000822.
- BackgroundBeauchaine, T. P., & Crowell, S. E. (Eds.) (2020). The Oxford handbook of emotion dysregulation. NY: Oxford University Press.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore P Beauchaine, PhD principal investigator
University of Notre Dame
Brooke A Ammerman, PhD principal investigator
University of Notre Dame
Kristin Valentino, PhD principal investigator
University of Notre Dame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Transcutaneous Nerve Stimulation (tVNS) in people with Nonsuicidal Self Injury and Alcohol Abuse, run by University of Notre Dame at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30 (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343039, which also lists 118 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.