Clinical Research

Demonstrating clinically meaningful reductions in depressive symptoms

SparkRx has been studied in a nationwide, randomized controlled trial (NCT05462652). The results showed clinically meaningful ¹⁻² reductions in depressive symptoms.

Pivotal Trial Intention-to-Treat Analysis

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 clinical research summary

Learn more about SparkRx

SparkRx is available now under the FDA’s policy to treat psychiatric disorders during COVID-19. Providers interested in offering SparkRx to their patients can visit the SparkRx website to register and view important safety information. Teens and young adults can also visit the website to learn more about how to get access to SparkRx.

Visit the SparkRx website

Grounded in Clinically Validated Treatment

Cognitive-behavioral therapy (CBT) has been shown to be effective in the prevention and treatment of depression in children and adolescents, and is recommended as a first-line treatment for depression by the American Academy of Pediatrics.

Because certain neural systems in the brains of adolescents are still developing, teenagers demonstrate more reward-seeking behaviors than adults and have a greater tendency to engage in harmful and avoidant behaviors during depressive episodes. 

Reinforcing healthy behaviors and social engagement may be particularly helpful for treating depression in adolescents. A focus on psychoeducation and encouraging and reinforcing positive behavior may also be appealing to teenagers who struggle with the corrective approach that supports some traditional therapy models.

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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).

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).

5. Coley, 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).

Additional References
McCauley, E., Gudmundsen, G., Schloredt, K., Martell, C., Rhew, I., Hubley, S., & Dimidjian, S. (2015). The Adolescent Behavioral Activation Program: Adapting Behavioral Activation as a Treatment for Depression in Adolescence. Journal of Clinical Child & Adolescent Psychology, 45(3), 291–304.

McCauley, E., Schloredt, K. A., Gudmundsen, G. R., Martell, C. R., & Dimidjian, S. (2016). Behavioral Activation with Adolescents: A Clinician’s Guide (Illustrated ed.). The Guilford Press.

Pass, L., Hodgson, E., Whitney, H., & Reynolds, S. (2018). Brief Behavioral Activation Treatment for Depressed Adolescents Delivered by Nonspecialist Clinicians: A Case Illustration. Cognitive and Behavioral Practice, 25(2), 208–224.

Pass, L., Lejuez, C. W., & Reynolds, S. (2017). Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study. Behavioural and Cognitive Psychotherapy, 46(2), 182–194.

FCOI Policy

SparkRx Important Safety Information

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:  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