One in five pre- or postnatal women will develop a perinatal mood disorder (PMD). While temporary and treatable, 50-65% of mothers with PMD symptoms never receive a diagnosis or treatment due to inadequate screening practices. PMDs remain undetected because mothers do not trust clinicians due to fear of judgment, stigma, or even loss of parental rights. Untreated PMDs increase risk for maternal mortality, maternal suicide, preterm birth, low birth weight, and adverse childhood experiences. There is an urgent unmet need for comprehensive, real-time perinatal mental health monitoring to connect women to effective treatment. To meet this need, BetterHope LLC (dba Poisera) is developing a technology platform to systemically monitor, screen, refer, and treat PMDs for women from early pregnancy through 36 months postpartum. The platform includes a mobile health (mHealth) app, where a chatbot conversationally engages mothers in daily reflection exercises about pregnancy, motherhood, and mental health. Each week, the chatbot prompts mothers to complete a state-of-the-art, validated adaptive diagnostic screening for PMDs. When a woman screens positive for PMD symptoms, the Poisera platform connects the woman to a Psychiatric Perinatal Access Program (PPAP), where a behavioral health clinician (BHC) will assess risk, deliver a brief therapeutic intervention, and coordinate long-term treatment. BHCs update her risk profile and treatment information in Poisera's dashboard, where the patient's clinician can track treatment progress. PPAPs exist in 30 states. PPAPs are proven to improve PMD symptoms and guarantee continuity of care. Using a chatbot to longitudinally monitor and screen for PMDs is an innovative approach because chatbots promote honest disclosure and increase adherence. Further, the Poisera platform transforms the current, inadequate clinical practice for PMD screening and treatment to one where clinicians are confident their patients receive effective treatment at PMD onset because the information is seamlessly integrated into their clinical workflow. The long-term goal of this research is to eliminate adverse health consequences from PMDs. In this Phase I SBIR, we will demonstrate the Poisera platform meets the needs of both pregnant women and clinicians. In Aim I, we will demonstrate that pregnant women find the Poisera app and chatbot usable. In Aim 2, we will demonstrate obstetric clinicians find the Poisera dashboard usable in their clinical workflows. In Aim 3, we will conduct a two-arm feasibility randomized controlled trial (RCT) to measure screening adherence and determine dropout behavior. These outcomes will inform the design of our Phase II RCT, where we aim to demonstrate the Poisera platform cost-effectively improves PMD outcomes for women from pregnancy to 36 months postpartum. Demonstrating effective outcomes on these measures will provide us with the validation needed to sell the Poisera platform to health systems and health insurers, a $2.8 billion annual market size.
Public Health Relevance Statement: PUBLIC HEALTH RELEVANCE STATEMENT Perinatal mood disorders (PMDs) are the most common health complication from pregnancy, and though treatable, most mothers with PMD symptoms never receive diagnosis or treatment. In this SBIR, BetterHope LLC (dba Poisera) will develop a mobile health app to longitudinally monitor perinatal mental health to improve detection and delivery of treatment for PMDs. The Poisera app will identify and treat PMD at earliest onset for 750, 000-800, 000 women each year to avoid long-term adverse health outcomes for both mother and child.
Project Terms: Behavior; Mental disorders; Mental health disorders; Psychiatric Disease; Psychiatric Disorder; mental illness; psychiatric illness; psychological disorder; Child; 0-11 years old; Child Youth; Children (0-21); kids; youngster; Continuity of Patient Care; Continuity of Care; Continuum of Care; cost effectiveness; Diagnosis; Disclosure; Information Disclosure; Dropout; Empathy; Exercise; Fright; Fear; Goals; Health; Low Birth Weight Infant; low birth weight; low birthweight; Insurance Carriers; Insurers; Interview; Judgment; Marketing; Maternal Mortality; maternal death; Mental Health; Mental Hygiene; Psychological Health; Mothers; Discipline of obstetrics; Obstetrics; Patients; Pregnancy; Gestation; Pregnancy Complications; complications during pregnancy; pregnancy-related complications; Pregnant Women; expectant mother; expecting mother; pregnant mothers; Research; Rights; Risk; Suicide; fatal attempt; fatal suicide; intent to die; suicides; Surveys; Survey Instrument; Technology; Time; Woman; Measures; Developmental Delay; Specific Child Development Disorders; Developmental Delay Disorders; post-partum; Postpartum Period; Risk Assessment; Prematurely delivering; Preterm Birth; premature childbirth; premature delivery; preterm delivery; Premature Birth; Peripartum; Perinatal; improved; Clinical; Phase; Ensure; intuitive; Intuition; Licensing; Funding; disease onset; disorder onset; Onset of illness; randomized control trial; Randomized, Controlled Trials; Intellectual Property; motherhood; Knowledge; programs; postnatal; Mood Disorders; Affective Disorders; experience; treatment planning; prenatal; unborn; technological innovation; Health Technology; Health Care Technology; Healthcare Technology; Therapeutic Intervention; intervention therapy; Modeling; behavioral health; social stigma; stigma; Intervention; Intervention Strategies; interventional strategy; Address; Health system; Symptoms; Adherence; Data; Detection; Enrollment; enroll; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Update; Validation; validations; Monitor; Development; developmental; Evidence based treatment; cost; digital; designing; design; Outcome; innovate; innovative; innovation; usability; commercial application; prototype; public health relevance; effective treatment; effective therapy; clinical practice; Secure; arm; screenings; screening; mobile app; mobile device application; mobile application; maternal morbidity; attentional control; application program interface; application programming interface; diagnostic screening; dashboard; perinatal mental health; Mobile Health App; m-Health app; m-Health application; mHealth app; mHealth application; Mobile Health Application; adverse childhood experiences; adverse childhood events; early pregnancy; chat bot; chatbot; maternal risk; United States Preventative Services Task Force; U.S. Preventative Services Task Force; U.S. Preventative Task Force; U.S. Preventive Services Task Force; U.S. Preventive Task Force; US Preventative Services Task Force; US Preventative Task Force; US Preventive Health Services Task Force; US Preventive Services Task Force; US Preventive Task Force; USPSTF; United States Preventative Task Force; United States Preventive Services Task Force; United States Preventive Task Force; technology platform; technology system
