SparkRx has been studied in a nationwide, randomized controlled trial (NCT04524598). The results showed clinically meaningful ¹⁻² reductions in depressive symptoms.
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).
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).
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.
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).
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.
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.
Interested in partnering for clinical research? Please contact: research@limbix.com
Footnotes
1. 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).
2. 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).
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. https://doi.org/10.1080/15374416.2014.979933
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. https://doi.org/10.1016/j.cbpra.2017.05.003
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. https://doi.org/10.1017/s1352465817000443
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
Digital therapeutics for adolescent mental health
