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:
tVNS to target emotion dysregulation,
a peer-support phone app to target social isolation,
tVNS + a peer-support phone app, or
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.