FAQs

How can I get my patients started with SparkRx?

To get your patients started with SparkRx, you’ll need to complete our provider access form. Once you’ve submitted this form, you’ll receive an email containing your unique access code, which your patients will use to make accounts in the SparkRx app. This email will also contain other important documents you’ll need to make informed decisions when recommending SparkRx to patients.

What are the Indications for Use for SparkRx?

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 FDA’s emergency guidance for digital health devices treating psychiatric disorders.

For full safety information, read the SparkRx Clinician Instructions for Use.

Is SparkRx cleared by the FDA?

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 FDA’s emergency guidance for digital health devices. For full safety information, please review the SparkRx Clinician Instructions for Use.

How is SparkRx used?

Please refer to our SparkRx Clinician Instructions for Use to learn more about how SparkRx is used by patients.

Does SparkRx replace a patients’ medication or therapy?

SparkRx is not meant to substitute any treatment or medication. For full safety information, read the SparkRx Clinician Instructions for Use.

Is SparkRx covered by insurance? How much does SparkRx cost?

SparkRx is currently being offered at no cost to patients, regardless of their insurance coverage, under the FDA’s emergency guidance for digital health devices treating psychiatric disorders.

What is a digital therapeutic and how is it different from other health apps?

A digital therapeutic is a program delivered through a digital device that provides an evidence-based therapeutic intervention or interventions intended to prevent, manage or treat a medical disorder or disease.

Health or wellness applications are not required to undergo the same clinical testing required for a digital therapeutic, and they are not intended or approved to treat specific medical disorders or diseases.

What safety features does SparkRx have?

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.

Providers and patients are instructed to read their respective instructions for use before offering or using the SparkRx program. These contain SparkRx’s Indications for Use and warnings.

Once patients begin using the SparkRx app, they are informed during onboarding that the text they enter into the app is not monitored by a human and is not a means to communicate with their provider. They are instructed to reach out directly to their provider if safety concerns emerge, and to contact 911 in the case of a medical emergency.

All text field entries in the SparkRx app are automatically compared to a comprehensive list of words and phrases that could indicate intent to harm self. If language from this list is typed into the app, patients are immediately directed to crisis resources and reminded that they cannot contact their provider through the app. Crisis resources are also easily accessible from the SparkRx homepage 24/7.

What if my patient discusses harming themselves in the app while using SparkRx?

If your patient uses language that is included on the SparkRx app’s list of words and phrases that could indicate intent to harm self, which was built with input from experts in adolescent suicide prevention, they will be reminded that they cannot contact their provider through the app and directed to a list of crisis resources.

How does SparkRx monitor patients’ progress while they’re using SparkRx?

Every week, patients are prompted to complete a weekly check-in, or the PHQ-8.
Soon, providers will have the option to monitor patients’ clinical outcomes and program adherence through the Limbix Provider Portal. For more information about the Limbix Provider Portal, email info@limbix.com.

How can I check in on patients’ progress while they’re using SparkRx?

The Limbix provider portal, coming soon, will allow you to monitor your patients’ clinical outcomes and program adherence by viewing your patient's weekly PHQ-8 assessment results and real-time metrics about their engagement with the SparkRx program. For more information about the Limbix Provider Portal, email info@limbix.com.

How long does the SparkRx treatment last?

The SparkRx program was designed to be completed over the course of 5 weeks, but patients will have access to the app for 7 weeks in total. These 7 weeks begin the moment they log into the app with the access code you provide them. If you would like to extend access to the app for longer than 7 weeks, that can be arranged by contacting info@limbix.com.

Has SparkRx been studied in clinical trials? What do the results show?

SparkRx has been studied in clinical trials. You can read about the research behind SparkRx here.

Why do my patients need me to give them access to SparkRx?

SparkRx is not intended to be used as a standalone treatment without supervision of a health care provider. Providers must give their patients access to the program, and patients should remain under their supervision for the full length of the program.

Which of my patients qualify to use SparkRx?

SparkRx is intended for patients 13 to 22 years of age with symptoms of depression, 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 and are familiar with use of smartphone applications. 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.

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.

For full safety information, read the SparkRx Indications for Use and Clinician Instructions for Use.

Can SparkRx be offered to a patient more than once?

SparkRx can be offered to a patient on multiple occasions at the discretion of the health care provider. If your patient already has access to SparkRx and would like to have access for a longer period of time, contact info@limbix.com.

How do I get SparkRx?

If you’d like to use SparkRx, you’ll need to tell your health care provider. Then they’ll need to go to the SparkRx website to fill out a provider interest form. You can help them get here by guiding them to SparkRx.com. This will give them access to the things they need to offer SparkRx to their patients. Then they can give you a SparkRx access code. You will use the access code to download the SparkRx app and create an account to begin your Spark journey!

What is SparkRx? What is it for?

SparkRx is a kind of treatment called a digital therapeutic. Health care providers can give patients access to it. And patients can use it on a mobile device! Because of COVID-19, the U.S. Food and Drug Administration (FDA) is allowing treatments like SparkRx to be used before they get FDA clearance. SparkRx was made for patients between 13 and 22 years old with symptoms of depression. It was made to reduce these symptoms.

What is CBT?

CBT stands for cognitive behavioral therapy. CBT is an evidence-based treatment that helps individuals understand the connection between their thoughts, feelings, and behaviors. Behavioral activation (BA) is an evidence-based type of CBT treatment. BA focuses on how changing behaviors can be used to help change your mood.

Who should use SparkRx?

SparkRx was made for patients between 13 and 22 years old with symptoms of depression. They should also be able to read English at a 5th grade level, or higher. And they should understand how to use a smartphone app. For more safety information, read the SparkRx User Guide.

How much does SparkRx cost? Is it covered by insurance?

Right now, SparkRx is being offered for free. Patients with or without insurance can use SparkRx at no cost, as long as their doctor recommends it to them.

Is SparkRx supported by science?

Before SparkRx was ready to be used, it went through clinical testing. This testing had to be done to show that SparkRx can be helpful. It was also done to show it is safe. Limbix did a study with the most recent version of SparkRx. The users who used SparkRx during it reported fewer depression symptoms after using the app. No participants in the study experienced a serious adverse event or unanticipated adverse device effect. You can read more about the science behind SparkRx here.

Can SparkRx be used alone to treat symptoms of depression?

SparkRx should not replace the care of your provider. SparkRx should also not replace any medications you might be taking. You should be in touch with your provider about all decisions related to your treatment.

What is the time commitment for SparkRx?

Access to the program ends 7 weeks after the day you first log in. So that is the longest amount of time you can take to finish the program. SparkRx was made to be used over the course of 5 weeks. But you can move through the app at your own pace.

Can my parents or my doctor see my progress through SparkRx?

The things you enter into SparkRx are private. Limbix doesn't read the text you share in SparkRx, and they do not share any of your information with providers or parents. You can read the SparkRx Privacy Policy here to learn more.

How is information protected in the SparkRx app?

Limbix will do everything possible to protect the things shared in SparkRx. You can read the SparkRx Privacy Policy here to learn more.
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You should also do a few things to protect the things you share in SparkRx. Keep a password on your device. Also make sure you are the only one logging into your SparkRx account.

I have more questions about SparkRx. Where should I ask them?

You can contact the Limbix team at info@limbix.com.

Why is the SparkRx program 5 weeks? Does it have to be completed in 5 weeks?

The SparkRx program has 5 levels. Each level was made to take about a week to complete. Patients should try to finish the program in 5 weeks. But they will have access to the app for 7 weeks in total.

Is an internet connection required to use SparkRx?

Most of SparkRx’s features are available offline. However, internet will be needed to log into the SparkRx app. It will also be needed to complete weekly check-ins.

Can SparkRx be used on a computer?

SparkRx can't be used on a computer. It can only be used on a smartphone device or a tablet. For the best experience, we recommend using SparkRx on a smartphone.

Can SparkRx only be used on smartphones?

SparkRx can be used on smartphones and tablets. They need to be the following versions: Apple iOS 11.0 or above Android 5.0 or above.
‍For the best experience, we recommend using SparkRx on a smartphone.

If I have trouble with my access code, what should I do?

If you have trouble with your access code, contact info@limbix.com.

Where should I go to find other treatments for my depression?

You should be in contact with your provider about all decisions related to your treatment. You can also visit the websites below to learn more about adolescent depression and common treatment options.
The Centers for Disease Control and Prevention
The American Academy of Child and Adolescent Psychiatry
The National Institute of Mental Health
The National Alliance on Mental Illness
The American Psychological Association

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