A Centralized Clinical Research Tool for Accelerating the Development, Evaluation, and Dissemination of Expert-Developed, Evidence-Based, and AI-Enhanced Digital Mental Health Therapies

PROJECT SUMMARY/ABSTRACT Mental health burden in the US is substantial [1-3], with millions of people lacking access to effective and timely mental health care [4-6]. Although digital mental health technologies hold great promise for addressing this crisis [7-9], widescale adoption of digital health has faced significant challenges, including the high costs of developing therapy apps, complex and expensive regulatory barriers, fragmented user adoption, and a lack of trust among providers and patients [10-12]. Colliga addresses barriers to digital mental health adoption via a centralized “hub” that supports the fast and inexpensive development, testing, and dissemination of evidence-based, AI-enhanced mental health apps. Colliga provides a comprehensive technological ecosystem where scientists, providers, and patients can collaborate seamlessly. Colliga’s integrated platform design enables scientists to develop, test, and publish custom AI-enhanced mental health therapy apps on the App and Google Play stores instantly and at no cost to them using our point-and-click web tool. Providers and patients benefit from easy-to-access, curated, and scientifically validated mental health apps tailored to patient needs, thus enhancing clinical decision-making and expanding treatment options. Colliga’s goal is to democratize access to high-quality and evidence-based mental health care by fostering wider adoption and sustainable use of effective digital therapies. Our parent Fast-Track SBIR award (R44MH123368, Ahle, Timmons, Comer) funded the development of the platform system, adaptive AI sensing technology, and a proof-of-concept randomized clinical trial for the first test case app on the platform, the TIES Parenting program, a transdiagnostic app for kids 6-9 years and their parents. Promising preliminary results from this randomized clinical trial position Colliga for further expansion through collaboration with scientist partners to launch follow-on programs across key mental health domains to expand Colliga’s offerings and use cases. Commercialization Readiness Pilot Program funding is needed to transition this promising and innovative technology from the research and development phase to commercial readiness by enhancing the technological infrastructure to ensure reliability and security for clinical deployment at scale (Aim 1), implementing final feature enhancements needed for clinical usability, adoption, and engagement (Aim 2), and executing commercialization and regulatory strategic plans in critical domains (Aim 3). These commercialization activities will position Colliga as a scalable and sustainable digital mental health platform capable of reaching diverse populations and meeting clinical standards for widespread adoption. Our innovative approach combines user-friendly development tools, a secure and scalable platform “hub,” and customizable AI technology to set new standards for ethical, inclusive, and evidence-based digital mental health solutions for all. By streamlining the path from research to real-world clinical application, Colliga accelerates scientific advancements, broadens access to effective therapy apps, and empowers scientists and mental health providers to deliver high-quality care. These efforts aim to improve mental health outcomes for all people, with the goal of creating a lasting and positive impact on public mental health.