A narrative review of app- and internet-delivered headache interventions: From ideation to implementation and the...

BackgroundThere is an increasing trend in the use of the internet and smartphone applications to deliver headache interventions. However, their efficacies remain unclear. Moreover, developing such interventions can be cumbersome and increasingly challenging when navigating the regulatory landscape of medical devices. The present study aimed to review the literature on internet- and app-based headache interventions and discuss opportunities and challenges in the process of developing such interventions.MethodsThis narrative review was based on a comprehensive literature search of PubMed. Publications investigating internet- and app-delivered interventions for headache disorders were identified, systematically assessed and summarised.ResultsInternet- and app-delivered interventions were mainly applied to deliver behavioural change techniques and relaxation training, coordinate management plans with patients, and promote medication adherence. Eleven randomised controlled trials, including two large-scale studies, did not demonstrate clear superiority of internet-delivered behavioural therapy over other therapies or waitlist control. Internet-delivered relaxation training trials might be more promising; however, they are old and less robust. Most studies investigating app-delivered behavioural therapy and relaxation training are pilot and feasibility trials, making it difficult to conclude their efficacy. Using the Internet and apps to manage care plans and promote medication adherence seems feasible, resulting in positive impacts on individual disease burden, health care and societal costs. However, these applications require further investigation.ConclusionsWe discussed important aspects of the conceptualisation, design and development of internet- and app-delivered interventions for headaches and provided specific recommendations to develop these interventions. Thereafter, we described and discussed the regulatory pathways for software interventions, which, in most cases, are considered medical devices and are subject to stringent regulations. Adhering to these regulations and creating a usable intervention with the evidence of efficacy established through robust clinical trials is time-consuming and requires medical, technological and regulatory knowledge.