Indications for Use
SparkRx is a digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy - Behavioral Activation) in patients 13 to 22 years of age as adjunct treatment for symptoms of depression.
SparkRx has not been cleared or approved by the U.S. Food and Drug Administration. During the COVID-19 public health emergency, SparkRx is being made available without a prescription under the FDA’s emergency guidance for digital health devices treating psychiatric disorders.
Important Safety Information for SparkRx
Working with a health care provider: Make sure to talk to your provider before starting SparkRx. You should also stay under their care for the full length of the program. SparkRx should not replace the care of your provider. SparkRx should also not replace any medications you might be taking.
Reaching out for help: Your provider will not see the things you type into the SparkRx app. So you should never use the app to try to reach them or get their advice. If you need to reach your provider, you’ll have to contact them outside of the SparkRx app.
Keeping you safe: SparkRx was not designed to treat or prevent thoughts of suicide. Let your provider know if you have thoughts about suicide or self-harm while using SparkRx. If you are in an emergency, go to the nearest emergency room or call 911.
Protecting your privacy: The things you share in SparkRx include sensitive medical information. Because of this, you should keep your smartphone or tablet password-protected. You should also be the only one logging into SparkRx using your smartphone or tablet.
