The Mental health Technology Assessment of Quality (MTAQ): Development of a novel quality assurance framework for digital mental health tools (Preprint)

BACKGROUND The rapid growth of digital mental health tools offers accessible support for a growing global population with mental health needs. However, concerns exist regarding their safety, efficacy, and overall quality, particularly for tools used outside of healthcare settings. The lack of regulation exacerbates these issues, and existing quality assurance frameworks are limited in scope and not specific to mental health, failing to address crucial aspects such as user experience and evidence-based practices. OBJECTIVE This study aims to develop a novel, comprehensive, and pragmatic quality assurance framework specifically tailored to digital mental health tools – the Mental health Technology Assessment of Quality (MTAQ). METHODS A convergent mixed-methods design was employed to develop the framework. Participants included mental health service users, academic and health professionals, and digital health provision experts. Quantitative survey data (N=309) were collected and then analysed descriptively to evaluate stakeholder priorities across three domains: user experience, data, and evidence. The survey gathered broad insights into the relative value of various quality factors, supplemented by qualitative data from focus groups and interviews (N=101), which provided richer perspectives in relation to the initial, literature-derived domains. The qualitative data were analysed thematically using a deductive approach. RESULTS The study found that intuitive, accessible, user-centred design; robust data privacy and security measures; and rigorous evidence were important to consider when assessing the quality of digital mental health tools. These insights led to the development of MTAQ, covering key quality domains and a structured assessment process. CONCLUSIONS The MTAQ framework provides the first comprehensive quality assurance framework and criteria specifically for digital mental health tools. By aligning research evidence, stakeholder input, and clinical perspectives, this framework offers a pragmatic, user-informed standard that has broad application to improving the design, assessment, quality, and trustworthiness of tools in this rapidly evolving field.