Efficacy of an unguided digital intervention for adults with attention-deficit/hyperactivity disorder: A randomized clinical trial

BACKGROUND: Psychotherapy for adults with ADHD is still underutilized in Germany and worldwide. Only a small percentage of these patients receive psychotherapy as recommended in the guidelines. Unguided digital interventions may help to lessen this treatment gap. METHODS: An open-label, exploratory randomized controlled trial was conducted (trial registration: DRKS00033320). Adults with confirmed ADHD were recruited at six study centers in Germany, as well as via social media, and were randomly allotted to receive either the intervention (treatment as usual + app) or the control condition (treatment as usual). Data were collected from 2 February to 5 June 2024. The primary endpoint was patients' health-related quality of life (QOL) at 12 weeks. The secondary endpoints included changes in the severity of ADHD symptoms, functional impairment, and symptoms of anxiety or depression. The threshold for statistical significance was set at 10% in view of the exploratory nature of the trial. RESULTS: = 0.54; 90% confidence interval [0.33-0.74]), despite generally low adherence to the intervention in the intervention group. 40% of subjects in the intervention group attained clinically relevant improvement in QOL, compared to 27% of control subjects. Among the secondary endpoints, ADHD symptoms improved to a greater extent in the intervention group than in the control group. CONCLUSION: Limitations include that no standardized diagnostics were conducted within the study and that no conclusions can be drawn regarding long-term effects.