Intended 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 enforcement policy for digital health devices treating psychiatric disorders.
Warnings (for Clinicians)
This app is not an emergency service provider. Patients experiencing a mental health emergency or having thoughts of self harm and suicide, should call 911 or go to the nearest emergency room.
Patients can also call or text 988, a 24/7 suicide and crisis lifeline. Patients will be connected to a trained crisis worker who can help them find support right away.
Patients should be clearly instructed not to use SparkRx to communicate severe, critical, or urgent information to their health care provider. Patients should also be informed that text they enter into SparkRx will not be monitored or reviewed by a health care provider. SparkRx is not meant to be used as treatment without supervision of a health care provider. Please instruct your patients to contact you should they notice a worsening of symptoms or an increase in thoughts of suicide or self-harm.
SparkRx is not meant to be a substitution for any treatment or medication.SparkRx is intended for patients whose primary language is English with a reading level of 5th grade or above, and who have access to an Android/iOS smartphone or tablet. SparkRx is intended only for patients who own a smartphone or tablet and are familiar with use of smartphone or tablet apps (applications).
SparkRx contains sensitive medical information. Please instruct patients to protect their information by password protecting their smartphone or tablet, and ensuring no one else may access their device.
SparkRx does not address concerns of active suicidal ideation with intent. SparkRx is not intended for the prevention of suicide attempts or self-harm behaviors. Patients with active suicidal ideation with intent or those who have had a past suicide attempt may still be given SparkRx to help treat depression but should not be given SparkRx to prevent, treat or mitigate active suicidal ideation with intent.
Patients with posttraumatic stress disorder (PTSD) who are currently experiencing marked alterations in arousal or reactivity associated with traumatic events may find that the level of exposure related to guided behavioral activation exacerbates symptoms.
Rev 1.1, 2022-09-28
