Randomized Controlled Trial of Starship Rescue: A Cognitive Behavior Therapy and Biofeedback-Based Computer Game to Treat Anxiety in Children and Young People with Long-Term Physical Conditions.

Objectives: This study was undertaken to investigate the comparative efficacy of a cognitive behavior therapy and biofeedback-based computer game (Starship Rescue: Vortex of Anxiety [SRVA]) and placebo well-being-focused computer game (Starship Rescue: Voyage of Wellness) for reducing symptoms of anxiety and improving quality of life among children and young people aged 8-18 with long-term physical conditions (LTPCs). Materials and Methods: A randomized controlled trial was conducted with 60 participants (30 per arm). Primary outcomes were change in anxiety symptoms on the Generalized Anxiety Disorder 7-item (GAD-7) and Spence Children's Anxiety Scale (SCAS) at 4 weeks. Secondary outcomes were changes in anxiety symptoms at 3 months; changes in quality of life using the Pediatric Quality of Life Inventory (PedsQL) at 4 weeks and 3 months; and acceptability of SRVA recorded at 4 weeks. Results: Participants in both groups experienced reduced anxiety (from a moderate to mild level) and improved quality of life at 4 weeks and 3 months. There were no significant group differences or time-by-group interactions observed for GAD-7, SCAS, or PedsQL. While SRVA was broadly acceptable, some suggestions for improvement of content and design were provided by users. Conclusions: Although this is the second study to demonstrate that SRVA can reduce levels of anxiety in children and young people with LTPC, previous questions regarding its efficacy and component-related benefits and new questions regarding the clinical value of physical health-oriented eHealth interventions remain unanswered. Further research is needed before SRVA can be recommended for clinical use.