Abstract
Background
The rapid growth of digital mental health tools offers accessible support to a growing global population with mental health needs. However, concerns remain regarding their safety, efficacy, and overall quality, particularly for tools used outside formal healthcare settings. Limited regulation and non-specific quality frameworks exacerbate these issues, often overlooking key elements such as user experience and evidence-based practice.
Objective
This study aimed to develop a comprehensive and pragmatic quality assurance framework for digital mental health tools, tailored to the needs of UK stakeholders.
Methods
A sequential mixed-methods design informed the development of the framework. Participants included mental health service users, academic and clinical professionals, and digital health experts. Survey data (N = 309) were analysed descriptively to identify stakeholder priorities across three core domains: user experience, data, and evidence. These findings were enriched by qualitative data from focus groups (N = 101), analysed thematically using a deductive approach to refine and extend the framework.
Results
Intuitive, accessible, user-centred design, strong data privacy and security measures, and robust evidence were identified as essential to quality assessment. These findings informed the development of MTAQ, which includes key domains and a structured process for evaluating tool quality.
Conclusions
The MTAQ framework is among the first quality assurance frameworks specifically designed for digital mental health tools. By integrating research evidence with lived experience, clinical, academic, technical, and commercial input, this offers a user-informed, practical standard to guide the development, assessment, and improvement of digital mental health technologies.