SparkRx

Offer SparkRx to patients today

SparkRx is a digital therapeutic that provides an evidence-based adjunct treatment intervention for adolescents aged 13-22 with symptoms of depression. We are offering SparkRx for a limited time under the FDA’s Enforcement Policy during the COVID-19 public health emergency.

For patients experiencing symptoms of depression

Ready to begin offering SparkRx?

Request a Demo

Offer SparkRx Today

Designed with clinical experts in adolescent depression

SparkRx brings evidence-based treatment to each patient’s smartphone, delivering a multi-week program based on cognitive behavioral therapy (CBT) and behavioral activation protocols.²

Behavioral activation

Patients learn about the relationship between mood and behavior and identify activities that can help them feel better. The program then helps them schedule and debrief on the activities.

Interactive tasks and rewards

Patients can gain a sense of progress and achievement as they complete interactive exercises and win rewards in the app. Limbot, the program’s robot guide, helps encourage patients throughout their treatment journey.

Built-in safety features

If language indicating potential self-harm is detected in the app, patients are shown crisis resources and emergency guidance. Crisis resources are also easily accessible from the SparkRx homepage.

Demonstrating clinically meaningful reductions in depressive symptoms

SparkRx has been studied in a nationwide, randomized controlled trial (NCT05462652). The results showed clinically meaningful³⁻⁴ reductions in depressive symptoms.

Explore the data

Teens who used SparkRx exhibited statistically lower depression severity by the end of treatment than a control group (p < 0.001). This statistically significant difference between groups remained one month after the intervention (p = 0.008). At the end of treatment, there was a statistically significant difference in remission rate (PHQ < 5; p < 0.01), in intervention response rate (50% reduction in symptoms; p < 0.001), and in rate of clinically-meaningful change (5+ point reduction in symptoms; p < 0.001).

Read our NEW clinical research summary

Read our prior clinical research summary

Offer SparkRx to patients today

A new treatment option for your patients is just a few steps away.

1. Sign up to offer SparkRx

Click the button below to be taken to our signup page, where you will enter basic information about your practice

2. Review the SparkRx Clinical Instructions for Use

This document contains important safety information and will help you determine if your patient can benefit from using SparkRx.

Read here → Clinicians Instruction for Use

3. Recieve your SparkRx patient access code via email

Give this code to your patients to allow them to create accounts in the app and begin their SparkRx journey!

Offer SparkRx Today

Request a Demo

Want real-time access to symptoms and progress?

The Limbix Provider Portal allows you to monitor your patients’ clinical outcomes and program adherence.
Coming soon!‍

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

References

¹ Keyes, K. M., Gary, D., O'Malley, P. M., Hamilton, A. & Schulenberg, J. Recent increases in depressive symptoms among US adolescents: trends from 1991 to 2018. Soc Psychiatry Psychiatr Epidemiol 54, 987-996 (2019).v
² Cheung, A. H., Zuckerbrot, R. A., Jensen, P. S., Laraque, D. & Stein, R. E. K. Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part II. Treatment and Ongoing Management. Pediatrics 141, e20174082 (2018).
³ Kroenke, K., Spitzer, R. L., & Williams, J. B. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med, 16, 606–613 (2001).
⁴ Forman-Hoffman, V. L., et al. Significant reduction in depressive symptoms among patients with moderately-severe to severe depressive symptoms after participation in a therapist-supported, evidence-based mobile health program delivered via a smartphone app. Internet Interv, 25, 100408 (2021).
⁵Coley, R. Y., Boggs, J. M., Beck, A., Hartzler, A. L., & Simon, G. E. Defining success in measurement-based care for depression: A comparison of common metrics. Psychiatr Serv, 71, 312–318 (2020).
⁶ Löwe, B., Unützer, J., Callahan, C. M., Perkins, A. J., & Kroenke, K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care, 42, 1194–1201 (2004).
⁷ Donkin, L., et al. Rethinking the dose-response relationship between usage and outcome in an online intervention for depression: randomized controlled trial. J Med Internet Res, 15, e231 (2013).

The first digital treatment for adolescent depression

More young people are being diagnosed with depression than ever before.¹ SparkRx is a treatment option with room for all of them.

Offer SparkRx to patients today

For patients experiencing symptoms of depression

Designed with clinical experts in adolescent depression

Behavioral activation

Interactive tasks and rewards

Built-in safety features

Demonstrating clinically meaningful reductions in depressive symptoms

Explore the data

Offer SparkRx to patients today

1. Sign up to offer SparkRx

2. Review the SparkRx Clinical Instructions for Use

3. Recieve your SparkRx patient access code via email

Want real-time access to symptoms and progress?

Intended Use

Warnings (for Clinicians)

References

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