Research Into Digital Health Intervention for Mental Health: 25-Year Retrospective on the Ethical and Legal Challenges.

Digital mental health interventions are routinely integrated into mental health services internationally and can contribute to reducing the global mental health treatment gap identified by the World Health Organization. Research teams designing and delivering evaluations frequently invest substantial effort in deliberating on ethical and legal challenges around digital mental health interventions. In this article, we reflect on our own research experience with digital mental health intervention design and evaluation to identify 8 of the most critical challenges that we or others have faced, and that have ethical or legal consequences. These include: (1) harm caused by online recruitment work; (2) monitoring of intervention safety; (3) exclusion of specific demographic or clinical groups; (4) inadequate robustness of effectiveness and cost-effectiveness findings; (5) adequately conceptualizing and supporting engagement and adherence; (6) structural barriers to implementation; (7) data protection and intellectual property; and (8) regulatory ambiguity relating to digital mental health interventions that are medical devices. As we describe these challenges, we have highlighted serious consequences that can or have occurred, such as substantial delays to studies if regulations around Software as a Medical Device (SaMD) are not fully understood, or if regulations change substantially during the study lifecycle. Collectively, the challenges we have identified highlight a substantial body of required knowledge and expertise, either within the team or through access to external experts. Ensuring access to knowledge requires careful planning and adequate financial resources (for example, paying public contributors to engage in debate on critical ethical issues or paying for legal opinions on regulatory issues). Access to such resources can be planned for on a per-study basis and enabled through funding proposals. However, organizations regularly engaged in the development and evaluation of digital mental health interventions should consider creating or supporting structures such as advisory groups that can retain necessary competencies, such as in medical device regulation.

Understanding Public Perceptions of Virtual Reality Psychological Therapy Using the Attitudes Towards Virtual Reality Therapy (AVRT) Scale: Mixed Methods Development Study.

BACKGROUND: Virtual reality (VR) psychological therapy has the potential to increase access to evidence-based mental health interventions by automating their delivery while maintaining outcomes. However, it is unclear whether these more automated therapies are acceptable to potential users of mental health services. OBJECTIVE: The main aim of this study was to develop a new, validated questionnaire to measure public perceptions of VR therapy (VRT) guided by a virtual coach. We also aimed to explore these perceptions in depth and test how aspects such as familiarity with VR and mental health are associated with these perceptions, using both quantitative and qualitative approaches. METHODS: We used a cross-sectional mixed methods design and conducted an exploratory factor analysis of a questionnaire that we developed, the Attitudes Towards Virtual Reality Therapy (AVRT) Scale, and a qualitative content analysis of the data collected through free-text responses during completion of the questionnaire. RESULTS: We received 295 responses and identified 4 factors within the AVRT Scale, including attitudes toward VRT, expectation of presence, preference for VRT, and cost-effectiveness. We found that being more familiar with VR was correlated with more positive attitudes toward VRT (factor 1), a higher expectation of presence (factor 2), a preference for VRT over face-to-face therapy (factor 3), and a belief that VRT is cost-effective (factor 4). Qualitative data supported the factors we identified and indicated that VRT is acceptable when delivered at home and guided by a virtual coach. CONCLUSIONS: This study is the first to validate a scale to explore attitudes toward VRT guided by a virtual coach. Our findings indicate that people are willing to try VRT, particularly because it offers increased access and choice, and that as VR becomes ubiquitous, they will also have positive attitudes toward VRT. Future research should further validate the AVRT Scale.

Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry.

BACKGROUND: To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood. OBJECTIVE: We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions. METHODS: The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required. RESULTS: Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs. CONCLUSIONS: There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.