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.
Learn how to offer 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, at no cost to patients or providers, under the FDA’s Enforcement Policy during the COVID-19 public health emergency.

For patients experiencing symptoms of depression

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 (NCT04524598). The results showed clinically meaningful³⁻⁴ reductions in depressive symptoms.

Explore the data

Participants with moderate to severe depression symptoms who received SparkRx (n = 63) showed a clinically meaningful reduction in depression symptoms (≥ 5 point symptom reduction across the intervention). At the end of the study, significantly more adolescents in the SparkRx group were in remission from depression compared to the control group (PHQ < 5; p = 0.01). At the end of treatment, 24% of SparkRx compared to 14% of Control participants had a treatment response (50% reduction in symptoms). The modified intention-to-treat analysis comparing SparkRx to the active control over the 5 weeks was not significant (p = 0.06).

Explore the data

For participants with moderate to severe depression symptoms who consistently engaged with the research protocol (n = 86), SparkRx led to a statistically significant reduction in depression symptoms compared to the active control (p = 0.01). Statistical significance was retained when controlling for multiple comparisons. At the end of treatment, 21% of SparkRx participants had depressive symptoms in the remission range (PHQ < 5) and 31% of SparkRx participants had a treatment response (50% reduction in symptoms).

Explore the data

Follow up analyses suggest that participants with mild to severe depression symptoms who received SparkRx (n = 74) showed a statistically significant reduction in depression symptoms compared to the active control (p = 0.003). At the end of the study, SparkRx participants showed a statistically significant improvement in treatment response (SparkRx = 30%; Control = 15%; p = .03) and remission rate (SparkRx = 27%; Control = 11%;  p = .01) compared to the Control group. Statistical significance was retained controlling for multiple comparisons.

Explore the data

For participants with mild to moderate depression symptoms (n = 109) that consistently engaged with the research protocol, SparkRx also led to a statistically significant reduction in depression symptoms compared to the active control (p = 0.001). Statistical significance was retained controlling for multiple comparison. At the end of treatment, 30% had depressive symptom scores in the remission range (PHQ < 5) and 39% of SparkRx participants had a treatment response (50% reduction in symptoms).

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
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The Limbix Provider Portal allows you to monitor your patients’ clinical outcomes and program adherence.
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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 Racine, N., et al. Global prevalence of depressive and anxiety symptoms in children and adolescents during COVID-19: a meta-analysis. JAMA Pediatr.. https://doi.org/10.1001/jamapediatrics.2021.2482 (2021).
² McCauley, E., et al.. The adolescent behavioral activation program: Adapting behavioral activation as a treatment for depression in adolescence. J Clin Child Adolesc Psychol 45(3), 291–304 (2016).
³ 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).
⁴ 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. 10.2196/jmir.2771 (2013).