HYBRID TYPE 1 EFFECTIVENESS-IMPLEMENTATION TRIAL FOR PRIMARY CARE DEPRESSION SCREENING AND REFERRAL TO A REMOTE DIGITAL MENTAL HEALTH CLINIC

ABSTRACT The global burden of depression is staggering: Affecting an estimated 7 to 10% of the adult U.S. population in any given year, depression’s high rates of comorbid conditions and association with impaired functioning and disability costs the U.S. approximately $200 billion per year. Issues continue to plague screening, recognition, and treatment for depression in primary care settings. Patients with depression are recognized as such, less than half of the time in the U.S, with 49.2% sensitivity and 81.1% specificity for accurately identifying patients having a current major depressive episode. Treatment for depression usually begins with primary care providers prescribing antidepressants and use of collaborative care models, however, patients experience many barriers to these treatments such as high costs, embarrassment in seeking help, and long waits for appointments. These treatments have also been shown to have only a short-term effect, and patients continue seeking treatment without finding an accessible and effective solution to alleviate their depressive symptoms. Meru Health Medical, P.A. developed a complete and clinically proven treatment program for depression, anxiety, and burnout with long-lasting outcomes. The Meru Health Program (MHP) is a 12-week, mobile app- based online digital mental health clinic overseen by a licensed clinical therapist and a psychiatrist. The delivery of the MHP seeks to overcome many of the barriers that can hinder the receipt of mental health services such as improved access and less stigma. This SBIR Direct-to-Phase II application is aimed to conduct a multi-site Hybrid Type 1 Randomized Control Trial (RCT) of the MHP among adults who screen positive for depression in primary care to prepare for the program’s rapid dissemination. This application proposes a proof-of-concept study to develop and optimize the study materials, test the screening, referral, and study enrollment procedures in preparation for a 300-patient multisite RCT. Following, a multistakeholder process evaluation of the delivery of the MHP intervention will be conducted to guide the set-up of subsequent studies and to better understand contextual factors for implementation. The study design allows simultaneous testing of the effectiveness of the clinical intervention on relevant outcomes while observing and gathering information on implementation which is requisite for the program’s rapid dissemination. The unique benefit of the MHP is in its discreet administration to patients with the treatment modalities and approaches utilized in the program, validated by high quality studies showing significant proof of efficiency. Meru Health Medical, P.A. is committed to cutting-edge research conducted with integrity as a way to continuously improve the MHP. This application will establish the feasibility of referral to the MHP via direct screening in a primary care setting, benefiting the high percentage of U.S. adults turning to primary care healthcare professionals who seek a long-lasting treatment method for depression.