Overview
GAIA reported positive results from a randomized controlled trial published in Psychological Medicine, demonstrating that attexis significantly reduced ADHD symptoms in adults.
The digital therapeutic also improved daily functioning, self-esteem, quality of life, and depressive symptoms, further supporting its role as an evidence-based treatment option.
Already listed in Germany’s DiGA directory, attexis is reimbursable through statutory health insurance and aims to improve access to adult ADHD care.
The News
The multicenter RCT enrolled 337 adults aged 18 years and older with confirmed ADHD diagnoses and evaluated attexis alongside treatment as usual (TAU) versus TAU alone. After three months, patients using attexis achieved a statistically significant and clinically meaningful reduction in ADHD symptom severity compared with the control group. The intervention also produced significant improvements in social and professional functioning, self-esteem, quality of life, and depressive symptoms. Researchers further noted that the digital therapy demonstrated effectiveness comparable to face-to-face psychotherapy while achieving strong user acceptance.
Developed by GAIA in collaboration with Saarland University Hospital, Mainz University Hospital, Bonn University Hospital, the University of Lübeck, and Kiel University, attexis is based on cognitive behavioral therapy and mindfulness techniques. The self-guided program delivers psychoeducation, therapeutic exercises, dialog-based coaching, introspection tools, and reminder functions, enabling integration into existing treatment plans. Following earlier positive evidence, the Federal Institute for Drugs and Medical Devices (BfArM) permanently included attexis in Germany’s DiGA directory in August 2025 as the country’s first digital therapeutic for adult ADHD. The therapy is marketed by Medice and is reimbursed by all statutory health insurance providers.
Industry Perspective
Adult ADHD remains significantly underdiagnosed and undertreated despite affecting an estimated 2 million adults in Germany, while initial diagnoses have tripled since 2015. Limited access to cognitive behavioral therapy due to therapist shortages and long waiting lists has increased interest in evidence-based digital therapeutics. Positive results from large randomized trials continue to strengthen the role of reimbursable digital health applications as scalable solutions for expanding access to guideline-recommended mental health care.
Strategic Impact
The findings strengthen the clinical evidence supporting attexis and reinforce the growing role of reimbursable digital therapeutics in addressing gaps in adult ADHD care. By offering a scalable, evidence-based CBT intervention, GAIA is helping expand access to guideline-recommended treatment while supporting better long-term patient outcomes.
Source: GAIA
