Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
- Conditions
- Suicidal IdeationSelf Harm
- Interventions
- Device: tVns ProgramOther: Enhanced Treatment as UsualOther: Phone App ProgramCombination Product: tVNS and Phone App Program
- Registration Number
- NCT05602779
- Lead Sponsor
- University of Notre Dame
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tVNS Program tVns Program 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. Enhanced Treatment as Usual Enhanced Treatment as Usual 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. Phone App Program Phone App Program 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. tVNS and Phone App Program tVNS and Phone App Program 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.
- Primary Outcome Measures
Name Time Method Changes from Baseline to Follow-up Assessments in Self-Injurious Thoughts and Behaviors over one year 30 Days; One Year Teens will be assessed at baseline visits for self-injurious thoughts and behaviors (non-suicidal self-injury (NSSI), suicidal ideation (SI), suicide attempts (SA)). They will complete measures individually on the Qualtrics Survey (SIQ) as well as participate in a face-to-face interview with a trained staff member to assess their level of NSSI, SI, and SA (CSSRS, DSHI).
All participants will repeat these tasks at all visits (post-treatment, one-year follow-up). We expect teens who have used the active tVNS device will show improved responses (e.g., decreases in NSSI and SI). Teens who have engaged in the peer-matched MindTiles condition will show improved responses in SI, SA, and NSSI. For both conditions we will examine rates of self-injurious thoughts and behaviors in the treatment arms in relation to national norms. We plan to examine between group change across treatment groups as well as within-person change at 30 days and one year post intervention.
- Secondary Outcome Measures
Name Time Method Change from Baseline to Follow-up Assessments in Emotion Dysregulation 30 Days; One Year Some teens will be randomized to the active tVNS condition where they will receive daily stimulation to their vagus nerve, which should modulate emotion dysregulation. Each participating teen will complete questionnaires regarding emotion dysregulation on the Qualtrics survey (Difficulties in Emotion Regulation Scale (DERS)) at all timepoints. We anticipate those who are randomized to the active tVNS condition will show improvement in emotion dysregulation at 30 days and one year post treatment relative to the other treatment arms, as well as show improved within-person change.
Change from Baseline to Follow-up Assessments in Social Connection and Loneliness 30 Days; One Year Some teens will be assigned to using the peer support phone app where they will be matched with another teen in the study. They will play a cooperative game with each other, and be able to text and share thoughts, feelings, etc. with each other during the 30 days intervention period. The peer-matched MindTiles app is expected to improve teen's self-reported feelings of isolation and loneliness.
Each participating teen will complete questions regarding feelings of loneliness and social isolation on the Qualtrics survey during all lab visits. We are using the 3 Item UCLA Loneliness scale and the INQ-15. We plan to examine between group change across treatment groups as well as within-person change at 30 days and one year post intervention.
Trial Locations
- Locations (2)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Notre Dame
🇺🇸South Bend, Indiana, United States