BackgroundPsoriasis has a negative impact on patients’ physical and mental health and can lead to anxiety and depression. Disease management strategies, including educational programs and eHealth devices, have been shown to improve health care for several chronic diseases. However, such disease management strategies are lacking in the routine care of patients with psoriasis.ObjectiveThis study aims to study the impact of a novel intervention that combines an educational program with a disease management smartphone app on the mental health of patients with psoriasis.MethodsPatients with psoriasis in the intervention group received an educational program; attended visits on weeks 0, 12, 24, 36, and 60; and had access to the study app. Patients in the control group only attended the visits. The primary endpoint was a significant reduction of scores on the Hospital Anxiety and Depression Scale (HADS). Secondary end points were reductions in Dermatology Life Quality Index score, Psoriasis Area and Severity Index score, pruritus, and pain, as well as improvements in mood and daily activities. In addition, modulating effects of sex, age, disease duration, and app use frequency were evaluated.ResultsA total of 107 patients were included in the study and randomized into the control group (53/107, 49.5%) or intervention group (54/107, 50.5%). Approximately 71.9% (77/107) of the patients completed the study. A significant reduction in HADS-Depression (HADS-D) in the intervention group was found at weeks 12 (P=.04) and 24 (P=.005) but not at weeks 36 (P=.12) and 60 (P=.32). Patient stratification according to app use frequency showed a significant improvement in HADS-D score at weeks 36 (P=.004) and 60 (P=.04) and in HADS-Anxiety (HADS-A) score at weeks 36 (P=.04) and 60 (P=.05) in the group using the app less than once every 5 weeks. However, in patients using the app more than once every 5 weeks, no significant reduction in HADS-D (P=.84) or HADS-A (P=.20) score was observed over the 60-week study period compared with that observed in patients in the control group. All findings were independent of sex, age, and disease duration.ConclusionsThese findings support the use of a disease management smartphone app as a valid tool to achieve long-term improvement in the mental health of patients with psoriasis if it is not used too frequently. Further studies are needed to analyze the newly observed influence of app use frequency.Trial RegistrationDeutsches Register Klinischer Studien DRKS00020755; https://tinyurl.com/nyzjyvvk