Depression affects more than 3.2 million adolescents in the USA, with rising incidence and suicide rates thatcarry devastating personal, societal, and economic impact. Effective care for adolescent depression is limiteddue to lack of access, shortage of providers, long waitlists, stigma, and ineffective or partially effectivepharmacological options. Many adolescents with depression are initially diagnosed and receive treatment fromprimary care providers, who, unfortunately, often have limited time, training, and options to be effectivegatekeepers for treatment. There is an urgent need for accessible, cost-effective, and clinically-validatedtreatment options for adolescents diagnosed with depression, particularly in primary care settings. Digitalhealth interventions represent an exciting and promising new direction for mental health treatment with strongpotential to increase access to care. Such technology is especially critical and timely during this period ofmandated physical distancing, which is expected to increase social isolation and exacerbate difficulties inreceiving care. Currently available commercial digital health options widely lack clinical validation, cannot makestrong medical claims, and are not specifically designed for adolescents. We aim to develop an FDA-cleared,self-guided, cognitive behavioral therapy (CBT)-based mobile program (Limbix Spark) to be prescribed byprimary care providers and psychiatrists and commercialized for at-home patient use as first line treatment.Limbix Spark implements behavioral activation, a key CBT skill that provides a sense of pleasure or masterythrough self-monitored activities to reduce depressive symptoms and improve functional outcomes. Givenyouth ease with and preference for technological solutions, an age-appropriate and engaging mobileintervention can be both beneficial and enjoyable. Building on outcomes from a feasibility trial demonstratinghigh feasibility and engagement, and preliminary evidence of clinically meaningful reductions in depressivesymptoms, in Phase I of the proposed Fast Track, we will conduct rigorous testing to optimize our Limbix Sparkprogram and show high usability, build a regulatory compliant platform, and prepare for a Phase II clinical trial.In Phase II, we will demonstrate clinical effectiveness of Limbix Spark by conducting a double-blind, placebocontrolled, randomized clinical trial with patients recruited and enrolled from primary care and psychiatricclinics. The team, led by veteran entrepreneurs, research professionals, industry leaders, and clinical experts,is singularly qualified to conduct the proposed research and commercialize Limbix Spark as an adolescentdepression prescription digital therapeutic, accelerating access to care for a severely underserved population.
Public Health Relevance Statement: Project Narrative
Depression impacts over 3 million adolescents in the United States, with incidence rates on the rise, yet there
are continued barriers to effective treatment. Digital health interventions based on cognitive behavioral therapy
represent a critical and exciting new direction for treatment and have the promise to reach an unprecedented
number of adolescents. The overarching goal of the proposed project is to develop a cost-effective,
clinically-validated, and engaging digital therapeutic that can be prescribed by pediatric primary care and
psychiatric providers in order to overcome a significant barrier in access to effective care for adolescents with
depression, a segment of the population with substantial unmet mental health needs.
Project Terms: Affect ; Age ; ages ; Mental disorders ; Mental health disorders ; Psychiatric Disease ; Psychiatric Disorder ; mental illness ; psychiatric illness ; psychological disorder ; Cognitive Therapy ; Cognition Therapy ; Cognitive Psychotherapy ; cognitive behavior intervention ; cognitive behavior modification ; cognitive behavior therapy ; cognitive behavioral intervention ; cognitive behavioral modification ; cognitive behavioral therapy ; cognitive behavioral treatment ; comorbidity ; co-morbid ; co-morbidity ; Mental Depression ; depression ; Diagnosis ; Double-Blind Method ; Double-Blind Study ; Double-Blinded ; Double-Masked Method ; Double-Masked Study ; Economics ; Feasibility Studies ; Feedback ; Goals ; Health Services Accessibility ; Access to Care ; access to health services ; access to services ; access to treatment ; accessibility to health services ; availability of services ; care access ; health service access ; health services availability ; service availability ; treatment access ; Incidence ; Industry ; Interview ; Mental Health ; Mental Hygiene ; Psychological Health ; Mission ; National Institute of Mental Health ; NIMH ; Patients ; Pharmacology ; Placebos ; Sham Treatment ; sham therapy ; Primary Health Care ; Primary Care ; Primary Healthcare ; Psychiatrist ; Research ; Safety ; Social isolation ; Suicide ; fatal attempt ; fatal suicide ; intent to die ; suicidality ; Technology ; Testing ; Time ; United States ; Veterans ; Waiting Lists ; waitlist ; Generations ; depressive symptoms ; Emotional Depression ; depression symptom ; depressive ; Youth ; Youth 10-21 ; Caring ; base ; improved ; Clinical ; Phase ; Medical ; Adolescent ; Adolescent Youth ; juvenile ; juvenile human ; Randomized Clinical Trials ; Training ; Childhood ; pediatric ; Patient Recruitments ; participant recruitment ; Phase II Clinical Trials ; Phase 2 Clinical Trials ; phase II protocol ; Life ; programs ; Notification ; Clinic ; meetings ; preference ; experience ; skills ; pleasure ; expectation ; Participant ; economic impact ; novel technologies ; new technology ; gatekeeper ; Gatekeeping ; Regulation ; psychoeducation ; stigma ; social stigma ; Adverse Experience ; Adverse event ; Intervention Strategies ; interventional strategy ; Intervention ; patient safety ; Provider ; clinical depression ; major depression ; major depression disorder ; Major Depressive Disorder ; International ; randomisation ; randomization ; randomly assigned ; Randomized ; Enrollment ; enroll ; Validation ; Monitor ; Teenagers ; Teen ; teen years ; teenage ; Development ; developmental ; Behavioral ; suicide rate ; digital ; Underserved Population ; under served group ; under served people ; under served population ; underserved group ; underserved people ; design ; designing ; child depression ; adolescent depression ; adolescents with depression ; childhood depression ; childhood onset depression ; depressed adolescents ; depression in adolescence ; pediatric depression ; youth depression ; functional outcomes ; Clinical effectiveness ; Outcome ; cost effective ; Population ; clinically significant ; clinical significance ; usability ; commercialization ; primary care setting ; primary outcome ; secondary outcome ; effective therapy ; effective treatment ; anxiety symptoms ; anxious symptom ; rate of change ; recruit ; care providers ; primary care provider ; phase 2 designs ; phase II designs ; feasibility trial ; digital treatment ; digital therapeutics ; digital therapy ; digital health ; Home ;
