Designing and Evaluating Digital Mental Health Interventions: Scoping Review.

Background: The ongoing adoption and use of digital interventions offer promising opportunities to meet the growing demand for mental health support. The effectiveness, implementation, and usage of these interventions depend on how well they are designed and evaluated. However, given the emerging nature of design research in this area, there is still no clear consensus on the specific principles and guidelines for developing digital mental health interventions (DMHIs). There seems to be a lack of clarity regarding the best practices for designing and evaluating these tools. Objective: We aimed to investigate and report on the design principles and evaluation approaches used in digital interventions specific to mental health care. Additionally, we sought to outline how these principles and approaches are applied in research. Methods: This scoping review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews. The literature search was performed in 2 electronic databases, SCOPUS and Web of Science, across 3 iterations from January 2024 to January 2025. A total of 2 independent reviewers screened and selected papers based on predefined inclusion and exclusion criteria, followed by data extraction from the selected studies. The data were then synthesized by categorizing the papers according to the primary research aim of each study. The inclusion criteria covered studies involving populations with mental health challenges or users of DMHIs, any digital tools for mental health care, and principles or strategies related to the design, evaluation, or implementation of DMHIs. Results: Our search identified 401 papers, of which 17 met the inclusion criteria for this review. Among these, 11 focused on evaluation studies, while 6 covered both design and evaluation studies (mixed). An iterative user-centered development process, expert inclusion, usability testing, specification of design elements, and user tracking and feedback were identified as common design principles used in studies focused on DMHIs. Evaluation approaches were shaped by the evaluation goal, which influenced the chosen methodologies. We also summarize the recommendations for implementation highlighted in some studies. Based on our findings, we propose 8 guidelines emphasizing stakeholder involvement in the development process and the need for clear justifications for design decisions, among other considerations. Conclusions: Design principles used in DMHI development include user-centered development, expert inclusion, and usability testing, while evaluation approaches often rely on randomized controlled trials to assess efficacy. Qualitative and mixed-method approaches are commonly adopted by studies to capture user experience and bridge both process and outcome measures. We recommend that future research explicitly report its design justification and adopt a multiperspective approach in the research and design of DMHIs.