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tVNS Program for Suicidal Thoughts

N/A

Recruiting

Led By Theodore Beauchaine, PhD

Research Sponsored by University of Notre Dame

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 13 and 17 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing two unconventional interventions to reduce suicidal thoughts, attempts, & death in teens. If successful, they could reach more teens & cost less than current methods.

Who is the study for?

This trial is for adolescents aged 13-17 who often feel impulsive or have trouble managing their emotions. They may feel very lonely, use alcohol or drugs, and must be able to meet in person in South Bend, IN or Rochester, NY. It's specifically for those who've hurt themselves on purpose multiple times without intending suicide.Check my eligibility

What is being tested?

The study tests two approaches: a noninvasive nerve stimulation therapy (tVNS) and a peer-support smartphone app. The tVNS aims to help with emotional control while the app addresses loneliness. These are compared against enhanced usual care to see if they can reduce suicidal behaviors more effectively.See study design

What are the potential side effects?

Potential side effects of the tVNS could include discomfort at the site of application or headaches. The phone app program might lead to increased screen time which can affect sleep patterns or cause eye strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 13 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Non-Suicidal Self Injury Behaviors at 30 Days

Improved Reports of Social Isolation and Loneliness

Improved Results from Participant's Typical Treatment

Secondary outcome measures

Adherence to tVNS and Phone App intervention from Baseline to 30 days.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: tVNS and Phone App ProgramExperimental Treatment1 Intervention

Adolescents will self-administer 30-minute tVNS (i.e., nerve stimulation) sessions daily for 30 days. They will receive a daily text message on their phone to remind them about their session. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey.

Group II: tVNS ProgramExperimental Treatment1 Intervention

Group III: Phone App ProgramExperimental Treatment1 Intervention

Adolescents will use a specially designed phone app to communicate with peers to help them cope with emotions, and to foster connection with peers to establish social connections. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey. The phone app will not be monitored during the night. If your adolescent needs immediate care during the night, please call 911 or your doctor's emergency contact number.

Group IV: Enhanced Treatment as UsualPlacebo Group1 Intervention

Enhanced TAU participants will be referred to and have access to available services within the community and, in addition to reports of their daily experiences via the sham app, will be called weekly to complete risk assessments during the active 30-day intervention stage.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterOTHER

840 Previous Clinical Trials

534,038 Total Patients Enrolled

University of Notre DameLead Sponsor

33 Previous Clinical Trials

61,382 Total Patients Enrolled

Theodore Beauchaine, PhDPrincipal InvestigatorWilliam K Warren Foundation Professor of Psychology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be the ideal candidates for this clinical trial?

"Entry to this clinical study necessitates the presence of suicidal ideation as well as being between 13 and 17 years old. The participants required for this trial total 212 people."

Answered by AI

Are elderly individuals eligible to enrol in this research endeavor?

"Based on the stipulations of this trial, adolescents aged between 13 and 17 are eligible to take part."

Answered by AI

Is there still an opportunity for participants to join this research project?

"Affirmative. According to the information listed on clinicaltrials.gov, this trial first launched on October 8th 2023 and was last revised November 29th of that same year. It is currently in search of 212 volunteers at one medical centre."

Answered by AI

How many participants is this experiment enlisting?

"Affirmative. Clinicaltrials.gov records demonstrate that this medical research, which was initially published on October 8th 2023, is currently recruiting participants. This clinical trial requires 212 individuals to be enrolled from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents

Theodore Beauchaine 2023. "Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05602779.