Effectiveness, User Engagement and Experience, and Safety of a Mobile App (Lumi Nova) Delivering Exposure-Based Cognitive Behavioral Therapy Strategies to Manage Anxiety in Children via Immersive Gaming Technology: Preliminary Evaluation Study

Background: Childhood anxiety disorders are a prevalent mental health problem that can be treated effectively with cognitive behavioral therapy, in which exposure is a key component; however, access to treatment is poor. Mobile-based apps on smartphones or tablets may facilitate the delivery of evidence-based therapy for child anxiety, thereby overcoming the access and engagement barriers of traditional treatment. Apps that deliver therapeutic content via immersive gaming technology could offer an effective, highly engaging, and flexible treatment proposition. Objective: In this paper, we aim to describe a preliminary multi-method evaluation of Lumi Nova, a mobile app intervention targeting mild to moderate anxiety problems in children aged 7-12 years using exposure therapy delivered via an immersive game. The primary objective is to evaluate the effectiveness, user engagement and experience, and safety of the beta version of Lumi Nova. Methods: Lumi Nova was co-designed with children, parents, teachers, clinicians, game industry experts, and academic partnerships. In total, 120 community-based children with mild to moderate anxiety and their guardians were enrolled to participate in an 8-week pilot study. The outcome measures captured the app's effectiveness (anxiety symptoms, child-identified goal-based outcomes, and functional impairment), user engagement (game play data and ease-of-use ratings), and safety (mood ratings and adverse events). The outcome measures before and after the intervention were available for 30 children (age: mean 9.8, SD 1.7 years; girls: 18/30, 60%; White: 24/30, 80%). Additional game play data were automatically generated for 67 children (age: mean 9.6, SD 1.53 years; girls: 35/67, 52%; White: 42/67, 63%). Postintervention open-response data from 53% (16/30) of guardians relating to the primary objectives were also examined. Results: Playing Lumi Nova was effective in reducing anxiety symptom severity over the 8-week period of game play (t29=2.79; P=.009; Cohen d=0.35) and making progress toward treatment goals (z=2.43; P=.02), but there were no improvements in relation to functional impairment. Children found it easy to play the game and engaged safely with therapeutic content. However, the positive effects were small, and there were limitations to the game play data. Conclusions: This preliminary study provides initial evidence that an immersive mobile game app may safely benefit children experiencing mild to moderate anxiety. It also demonstrates the value of the rigorous evaluation of digital interventions during the development process to rapidly improve readiness for full market launch.