Efficacy of the digital health application ORIKOⓇ for attention-deficit/hyperactivity disorder (ADHD) in adults: Protocol of a randomized controlled trial

Attention-deficit/hyperactivity disorder (ADHD) often continues into adulthood and affects several million adults in Germany. Many do not receive timely, evidence-based treatment because of long waiting times and limited access to care. Digital health applications offer a low-threshold option to provide guideline-based support. A pilot study of the present app-based program showed encouraging improvements in quality of life and reductions in ADHD symptom severity. This randomized controlled trial (RCT) aims to confirm and extend the pilot findings. The primary objective is to examine whether the digital intervention improves quality of life in adults with ADHD. Further outcomes include changes in ADHD symptoms, functional impairment, depressive and anxiety symptoms, substance use, general health, health literacy, medication adherence, and user satisfaction. A total of 380 adults with verified ADHD will be recruited online and via a university hospital. After informed consent and baseline assessment, participants will be randomized 1:1 to immediate access to a 12-week digital unguided program or to care as usual (CAU). Self-report assessments will take place at baseline, 6 weeks, and 12 weeks. Mixed models for repeated measures will be used for the primary analyses, complemented by intention-to-treat and complete-case approaches. The trial will test the robustness of the previous pilot results and provide evidence on the clinical value of a scalable digital intervention for adult ADHD.