A smartphone-based serious game for depressive symptoms: Protocol for a pilot randomized controlled trial

BACKGROUND: Depression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms. METHODS: This randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses. DISCUSSION: The study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.