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

NCT ID: NCT05602779

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2027-09-30

Brief Summary

Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence.

Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents' digital preferences. We will evaluate two unconventional but promising interventions delivered to 13- to 17-year-olds: transcutaneous vagus nerve stimulation to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. If effective, these digitally-delivered interventions could reach far more adolescents at far lower cost than current approaches.

Detailed Description

Over the past two decades, suicide rates have increased nearly 35% in the U.S., with upward trends in nearly all demographic groups. Further increases have occurred since the COVID-19 pandemic began. Despite ambitious goals for reducing suicides and significant federal and private investment, suicide rates continue to rise unabated. To date, the predominant approach to mitigating suicide risk in the U.S. is secondary prevention. Typically, these programs identify risk of recurrence among those who have already attempted suicide at least once. Although secondary prevention is crucial, the majority of deaths by suicide occur on first attempt. Thus, targeted primary prevention earlier in development is essential. Most current primary prevention programs are intensive, expensive, and delivered by highly trained mental health providers, who are in short supply. Traditional face-to-face therapy is also unavailable to many who live in underserved communities, and disliked by adolescents, who much prefer digital delivery on their devices. This high-risk, high-reward proposal addresses these limitations and needs. We use an experimental therapeutics approach to evaluate the independent and combined efficacies of two unconventional but scalable interventions: transcutaneous vagus nerve stimulation (tVNS) to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. These low-cost interventions, which hold strong promise but have not been used before, can reach large numbers of adolescents, with much potential to reduce prospective suicide risk. We will enroll 212 adolescents, ages 13-17 years, who show elevations on at least two prominent risk factors for suicide (e.g., self-injury, maltreatment).

Using a 2 × 2 design, adolescents will be assigned randomly to receive 30 days of treatment with:

1. tVNS to target emotion dysregulation,

2. a peer-support phone app to target social isolation,

3. tVNS + a peer-support phone app, or

4. enhanced treatment as usual with monitoring and access to resources.

Intervention effects on mechanisms (emotion dysregulation, social isolation) proximal efficacy signals (e.g., physiological reactivity, self-harm) and target outcomes (suicidal ideation, suicidal behaviors) will be evaluated immediately post-intervention and at one-year follow-up. Treatment data will be monitored daily to fine-tune dosing of both interventions. This transformative and innovative proposal tests two novel, scalable preventive interventions designed to "meet adolescents where they are" by using digital technologies to address core mechanisms of suicide risk.

Conditions

Self Harm; Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

tVNS Program + Control app

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. They will have access to MindTiles where they will complete daily puzzles on their own. 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 Type: EXPERIMENTAL

tVNS Program

Intervention Type: DEVICE

Participants will use the Neuvana Xen device 30 minutes a day for 30 days. The device delivers stimulation through the left ear via an ear bud. Participants can use the device at any time of day.

Phone App Program + Sham tVNS

Adolescents will use a specially designed phone app (MindTiles) to communicate with peer 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. Adolescents will also self-administer 30-minute sham tVNS (i.e., nerve stimulation) sessions daily for 30 days; these sessions will include no actual stimulation.

Group Type: EXPERIMENTAL

Phone App Program

Intervention Type: OTHER

Participants will have access to a specially designed phone app (MindTiles) in order to play a game designed for this study. Participants in the active intervention will be able to connect with a fellow participant who is matched as their peer for social support and they will complete a daily puzzle together and respond to a conversational prompt to encourage communication.

tVNS and Phone App Program

Adolescents will self-administer 30-minute tVNS (i.e., nerve stimulation) sessions daily for 30 days. Adolescents will also use a specially designed phone app (MindTiles) to communicate with a peer to help them cope with emotions, and to foster connection with peers to establish social connections. 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 Type: EXPERIMENTAL

tVNS and Phone App Program

Intervention Type: COMBINATION_PRODUCT

Participants will have both the Neuvana Xen Device and the full version of our program's phone app. They will use the device and full app access for 30 days.

Sham tVNS + Control App

Adolescents will self-administer 30-minute sham tVNS (i.e., nerve stimulation) sessions daily for 30 days; these sessions will include no actual stimulation.They will receive a daily text message on their phone to remind them about their session. They will also have access to MindTiles where they will complete daily puzzles on their own. 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 Type: SHAM_COMPARATOR

Sham tNVS and Control App

Intervention Type: OTHER

Participants will have access to our program's phone app so the can complete the daily puzzle on their own. They will also engage in a sham tVNS session for 30min per day for 30 days during which no stimulation is provided.

Interventions

tVNS Program

Participants will use the Neuvana Xen device 30 minutes a day for 30 days. The device delivers stimulation through the left ear via an ear bud. Participants can use the device at any time of day.

Intervention Type: DEVICE

Phone App Program

Participants will have access to a specially designed phone app (MindTiles) in order to play a game designed for this study. Participants in the active intervention will be able to connect with a fellow participant who is matched as their peer for social support and they will complete a daily puzzle together and respond to a conversational prompt to encourage communication.

Intervention Type: OTHER

tVNS and Phone App Program

Participants will have both the Neuvana Xen Device and the full version of our program's phone app. They will use the device and full app access for 30 days.

Intervention Type: COMBINATION_PRODUCT

Sham tNVS and Control App

Participants will have access to our program's phone app so the can complete the daily puzzle on their own. They will also engage in a sham tVNS session for 30min per day for 30 days during which no stimulation is provided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged between 13 and 17 years,
• Daily access to a smartphone
• Attend in person meetings in South Bend, IN or Rochester, NY. and,

Two of the following which will be scored during the phone screen:

• High scores on social isolation
• High scores on emotion dysregulation
• Has engaged in NSSI (inclusive of a single act)
• High T-scores on impulsivity,
• High T-scores on depression
• Engages in alcohol or other substance use

Exclusion Criteria

• Parent reported autism or schizophrenia
• Implanted pacemaker or cardiac defibrillator, other implanted or metallic device
• Pregnant or breast feeding
• History of seizures or epilepsy
• TMJ Disorder
• Bells' Palsy
• Impaired cranial nerve function
• Facial Pain

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

University of Notre Dame

OTHER

Sponsor Role: lead

Responsible Party

Kristin Valentino

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Valentino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Notre Dame

Locations

University of Notre Dame

South Bend, Indiana, United States

Site Status: RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheryl Lee, MS

Role: CONTACT

clee21@nd.edu

574-631-5097

Facility Contacts

Matthew Martinez

Role: primary

mmarti78@nd.edu

Cheryl Lee, MS

Role: backup

clee21@nd.edu

(574) 631-0950

Allan Shikh

Role: primary

Allan_Shikh@urmc.rochester.edu

585-602-2381

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

22-08-7372

Identifier Type: -

Identifier Source: org_study_id