A randomized controlled trial (RCT) published today in Psychological Medicine demonstrates a significant and clinically relevant reduction in ADHD symptoms in adults using the digital therapy "attexis". Researchers from GAIA in Hamburg, in collaboration with the Saarland University Medical Center, the University Medical Center Mainz, the University Hospital Bonn, the University of Lübeck, and Kiel University, investigated the efficacy of the digital intervention, which is already permanently listed in the DiGA (Digital Health Applications) directory. The results are of particular relevance since access to care is often limited for adults with ADHD in Germany and Europe.
The RCT enrolled 337 adults aged 18 and above with a confirmed diagnosis of ADHD. After three months of using attexis in addition to treatment as usual (TAU), a statistically significant and clinically relevant improvement in the severity of ADHD symptoms was observed in the intervention group compared to the control group (see figure). Furthermore, the group of attexis users showed significant and clinically relevant improvements in work and social functioning, self-esteem, and quality of life, as well as a reduction of depressive symptoms. It is particularly noteworthy that the digital therapy shows similar effect sizes to face-to-face psychotherapy for ADHD and is well received by users.
Dr. Gitta Jacob, licensed psychotherapist and head of the research and development department at GAIA, states: "The publication of our RCT in Psychological Medicine is an important milestone for us in ADHD research. The results provide robust clinical evidence that digital cognitive behavioral therapy interventions can provide adults with ADHD with effective and well-accepted treatment. I am particularly pleased that we are thus making a contribution to closing the care gap for those affected."
attexis is based on cognitive behavioral therapy (CBT) and mindfulness-based techniques. The therapeutic program conveys psychoeducation and therapeutic strategies in a conversational format. These dialogues are supplemented by self-monitoring and reminder functions. As a self-guided intervention, the therapeutic program can easily be integrated into existing treatment plans.
ADHD in adulthood represents a significant burden for those affected. Various aspects of functioning can be impaired, ranging from occupational performance to interpersonal relationships. It is estimated that around 2 million adults in Germany suffer from ADHD. The number of first-time diagnoses in adults has tripled since 2015.¹ Nevertheless, the disorder frequently remains unrecognized or inadequately treated in adulthood. Registry and health insurance data show that only a fraction of diagnosed adults receive guideline-compliant care. Psychosocial interventions—especially cognitive behavioral therapy (CBT)—are recommended in guidelines, but are scarcely available in many places due to limited therapy spots, long waiting times, and a lack of specialization.
Based on the positive study results, attexis was added to the DiGA directory by the Federal Institute for Drugs and Medical Devices (BfArM) in August 2025 as the first digital ADHD therapy for adults to be permanently listed. This means the therapeutic program can be prescribed by doctors and psychotherapists, and the costs are covered by all statutory health insurance providers. attexis is marketed in Germany by Medice.
About GAIA
GAIA is a global leader in the development of evidence-based, fully-automated and self-guided digital therapy systems that have benefited patients, physicians, and insurers for over two decades. Its product portfolio includes not only digital health applications (DiGA) but also numerous innovative therapeutics for mental health conditions, as well as other therapeutic areas such as immunology, rheumatology, MS, and back pain.
For over 25 years, GAIA has combined scientific, technological, and therapeutic expertise under one roof. Its goal is to support as many people as possible in restoring and maintaining their mental and physical health, thus improving their quality of life and well-being. The expert team at GAIA has confirmed the efficacy of its products in over 30 RCTs and meta-analyses. GAIA is the 48th member of the Association of Research-Based Pharmaceutical Companies (vfa). For more information, visit https://www.gaia-group.com.
Press contact:
Ulrike Voss
GAIA AG
Hans-Henny-Jahnn-Weg 53
22085 Hamburg
E-mail: presse@gaia-group.com
Telephone: +49 40 3510520
Psychological Medicine
Randomized controlled/clinical trial
People
Effectiveness of attexis, a digital intervention based on cognitive behavioral therapy for adults with ADHD: a randomized controlled trial
11-Mar-2026
LTB and GAJ are employees of GAIA, the developer, owner, and manufacturer of attexis. AP declares that she served on advisory boards, gave lectures, performed phase-3 studies, and received travel grants within the last 3 years from MEDICE Arzneimittel, Pütter GmbH and Co KG, Takeda, and Boehringer, and received royalties from books published by Elsevier, Hogrefe, Schattauer, Kohlhammer, Karger, Oxford Press, Thieme, Springer, and Schattauer. EF declares that she received royalties from Beltz Verlag and Elsevier Book; personal fees for supervision, workshops, and presentations on CBT, personality disorders, and posttraumatic stress disorder and depression; is co-chair of the Deutsche Fachverband für Verhaltenstherapie e.V. (unpaid); and received payments from GAIA for consulting activities for designing digital therapeutics for patients for BPD as well as for presentations on schema therapy.