Self-guided Treatment for Adolescents Navigating Depression
Depressive Symptoms, Depression, Depressive Disorder

About this trial
This is an interventional treatment trial for Depressive Symptoms focused on measuring Mental Health, Adolescents, Depression, Adolescent Mental Health
Eligibility Criteria
Inclusion Criteria:
- 13-21 years of age
- Self-reported symptoms of depression as assessed at eligibility screening
- English fluency and literacy (participant and legal guardian, if applicable)
- Access to a compatible smartphone (or other device) and operating system (i.e., capable of installing the app from the Google Play or Apple App Store; list will be provided on study website) and regular internet access
- Participant willing and able to provide informed consent/assent and have legal guardian willing and able to provide informed consent (if required)
- Under the care of a United States (U.S.)-based licensed healthcare provider and willing to provide contact information for the provider and sign a HIPAA release that allows Limbix to contact provider
- Willing and able to provide information required for study enrollment (e.g. all responses to initial PHQ-8 assessment, and current antidepressant medication status)
- Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the study period (up to 11 weeks after eligibility screening)
Exclusion Criteria:
- Diagnosis of (or treatment for) bipolar disorder, post traumatic stress disorder, psychotic disorder, substance use disorder, or eating disorder within the 12 months prior to eligibility screening
- Change in psychotropic medication (initiation or change in dose) within the 30 days prior to eligibility screening
- Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during the study intervention period (5 weeks) as determined at eligibility screening
- Suicide attempt within the past year
- Active suicide ideation with intent
- Previous participation in user testing or clinical testing of Spark or SparkRx, or other previous use of SparkRx app
- Participation in any other clinical research involving a mental health intervention or treatment within 60 days prior to eligibility screening
- Plans to participate in any other clinical research involving a mental health intervention or treatment during the study intervention period (5 weeks) as determined at eligibility screening
- Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the intervention or will prevent investigators from being able to ensure safety
- Having a sibling who is a past or current participant in the study
Sites / Locations
- Limbix Health, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Active Intervention
Usual Care
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.