This direct to Phase II SBIR proposal will study Appa Health, an adolescent-facing mental health smartphone and computer app. Appa combines (1) delivery of short-form digital evidence-based mental health content, emphasizing Cognitive Behavioral Therapy, via educational videos delivered by mental health experts who are internet influencers, with (2) trained and supervised near-peer mentors with relatable lived experiences who use supportive accountability to facilitate adolescents' use of the evidence-based content. According to Appa's theory of change, near-peer mentoring directly impacts adolescents' mental health and well-being via relational and instrumental support, but also indirectly through the acquisition of evidence-based skills (e.g., cognitive restructuring, behavioral activation) taught via educational videos. We will examine the psychosocial mechanisms of the two primary elements of Appa, establish the effectiveness of Appa on adolescent depression and anxiety, other measures of functioning, and theoretical mechanisms, and examine the cost-effectiveness of the full Appa experience as well as a video-only condition that Appa is considering marketing. Aim 1 will collect initial data and improve study procedures via a small pilot study. Seventy-five adolescents aged 13-18 with elevated scores on measures of depression and/or anxiety will be randomly assigned to one of three conditions: (1) near-peer mentoring and digital tools (Full Appa), (2) digital content only (Appa Light), and (3) waitlist control. Results will be used to optimize methodology to achieve study goals with minimum burden and maximum retention. Aims 2 & 3 will examine Appa's cost and effectiveness via a well-powered randomized clinical trial replicating the pilot trial using 400 adolescents. Variables will include clinical outcomes such as adolescent symptoms of depression, anxiety, and well-being, as well as treatment mechanisms and proximal outcomes. Because of the mental health workforce shortage, this study will have an impact on science by demonstrating the effectiveness of using laypersons (near-peer mentors) combined with expert digital content delivery and clinical supervision to support adolescents' mental health. This study is innovative in the unique combination of near-peer mentoring with evidence-based content delivered via youth-targeted TikTok-style videos conducted by existing internet influencers. Questions on how to increase adolescent engagement with and use of evidence-based skills are important to intervention developers. The data from this study will directly impact Appa's commercialization plan. Appa is scaling quickly, expanding from direct-to-consumer sales to partnerships with schools and self-funded employers, both of which are eager for documented clinical outcomes and identification of replicable mechanisms of change to ensure quality as Appa scales services. Cost-effectiveness analyses will drive development and design decisions (e.g., focusing resources on mentorship, content, or the mentorship-content integration), as well as commercialization decisions regarding target organizations and advertising.
Public Health Relevance Statement: PROJECT NARRATIVE. This partnership between Appa Health and the University of Washington will conduct a randomized controlled trial on the effectiveness and costs of a near-peer mentoring program coupled with videos on cognitive-behavioral therapy skills (Full Appa) as compared to videos alone (Appa Light) and a wait list control group. The study will include a pilot trial to optimize study procedures followed by a fully-powered effectiveness trial, and will collect experience and outcome data on adolescents over 12 weeks of the program. The results of this study will inform marketing and commercialization of Full Appa and possible development of Appa Light as a new product version.
Project Terms: Advertising; Affect; Anxiety; 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; Computers; Control Groups; Cost Analysis; Cost Analyses; assess cost; cost assessment; cost evaluation; evaluate cost; examine cost; cost effectiveness; Mental Depression; depression; Education; Educational aspects; Elements; Employment; Goals; Health; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Learning; Light; Photoradiation; Marketing; Mental Health; Mental Hygiene; Psychological Health; Mental Health Services; Mental Hygiene Services; mental health care; mental healthcare; Mentors; Mentorship; Methodology; Persons; Personal Satisfaction; well-being; wellbeing; Pilot Projects; pilot study; Quality of life; QOL; Research; Resources; Research Resources; Risk; Sales; Schools; Science; self esteem; Silicon; Si element; Supervision; Educational process of instructing; Teaching; United States; Universities; Use Effectiveness; effectiveness using; Waiting Lists; waitlist; Washington; diadenosine pyrophosphate; AppA; Accountability; Friends; Measures; Care Givers; Caregivers; Emotional Depression; depression symptom; depressive; depressive symptoms; Youth 10-21; Youth; Caring; improved; Procedures; Clinical; prematurity; premature; Phase; Adolescent Youth; juvenile; juvenile human; Adolescent; randomized, clinical trials; Ensure; Training; adult youth; young adulthood; young adult; Measurement; Early Intervention; Funding; WWW; web; world wide web; Internet; randomized control trial; Randomized, Controlled Trials; Therapeutic; tool; Knowledge; programs; physical conditioning; physical health; psychosocial; Services; experience; self help; Structure; skills; Participant; Prevention strategy; Preventative strategy; Preventive strategy; Prevention; Reporting; Sampling; psychoeducation; Intervention; Intervention Strategies; interventional strategy; Drops; Cell Phone; Cellular Telephone; Mobile Phones; iPhone; smart phone; smartphone; Cellular Phone; Effectiveness; Address; Symptoms; Age Years; Cost Effectiveness Analysis; cost efficient analysis; cost-effective analysis; Data; Randomized; randomisation; randomization; randomly assigned; Cognitive; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Teenagers; Teen; teen years; teenage; Development; developmental; Behavioral; effectiveness trial; pilot trial; cost; digital; effectiveness research; designing; design; adolescent depression; adolescents with depression; childhood depression; childhood onset depression; depressed adolescents; depression in adolescence; pediatric depression; youth depression; child depression; chronic mental illness; persistent mental illness; serious mental disorder; serious mental illness; severe mental disorder; severe mental illness; intervention efficacy; therapeutic efficacy; therapy efficacy; Treatment Efficacy; Clinical effectiveness; Outcome; cost effective; aged; Coupled; innovate; innovative; innovation; psychoeducational; commercialization; evidence base; improve symptom; symptom improvement; symptomatic improvement; arm; Adolescent and Young Adult; anxious symptom; anxiety symptoms; peer instruction; peer led team learning; peer mentoring; peer teaching; peer coaching; peer support; Theory of Change; care giver strain; caregiver strain; recruit; participant retention; strategies for implementation; implementation strategy; financial burden; financial distress; financial strain; financial stress; Financial Hardship; social relationships; digital mental health; digitally deliver; digital delivery; effectiveness study; pilot test; video delivery; video delivered; Equity; Meaning and purpose; digital tool; digital platform; TikTok
