A randomized controlled trial (RCT) on the digital health application levidex has now been published in the international journal Multiple Sclerosis Journal – Experimental, Translational and Clinical.[1] The LAMONT study shows that levidex significantly and clinically improves disease-specific quality of life in people with multiple sclerosis (MS). The study specifically focused on people with MS who had a reduced quality of life. Researchers from GAIA investigated the efficacy of levidex in collaboration with the University of Duisburg-Essen, the Neuromed Campus Hohenlind, NeuroTransData, the Vincera Clinics in Bad Waldsee, and the University Medical Center Hamburg-Eppendorf. The results are particularly significant given that disease-modifying drugs do not adequately address the psychosocial and emotional burdens of the disease—the so-called “invisible symptoms”.
The RCT included 470 people with MS who had impaired MS-specific quality of life (Hamburg Quality of Life Questionnaire for Multiple Sclerosis, HAQUAMS). Participants were randomized to receive either levidex in addition to usual care (TAU) or TAU alone; the primary endpoint was the HAQUAMS total score at six months. Compared with TAU alone, levidex + TAU significantly improved MS-specific quality of life. A clinically relevant improvement was achieved by significantly more participants in the levidex group than in the TAU-alone group. Positive effects were also observed for depressive symptoms, social and occupational functioning, and another MS-specific quality-of-life scale (MusiQoL). No serious adverse events occurred, and user satisfaction was high.
Dr. Björn Meyer, the study’s lead author and Head of Research at GAIA, says: “It is remarkable that the effects achieved are comparable in magnitude to those of significantly more resource-intensive psychosocial interventions, while the fully automated program can be used more widely and with lower barriers to entry.”
levidex is a web-based, self-guided digital health application for people with multiple sclerosis[2]. Based on cognitive-behavioral therapy and mindfulness-based methods, the program supports key areas of life such as coping with the disease, emotional well-being, nutrition, exercise, and sleep. The content is presented in a conversational format and supplemented by audio exercises and optional reminder functions.
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.
[1] Meyer, B., Nelles, G., Betz, L., Bergmann, A., Jauch-Chara, K., Krause, N., Riemann, K., von Glasenapp, B., & Heesen, C. (2026). Effectiveness of a digital health application (levidex) on quality of life in people with multiple sclerosis: A pragmatic, randomized controlled trial (LAMONT). Multiple Sclerosis Journal – Experimental, Translational and Clinical, 12(3), 20552173261475519. https://doi.org/10.1177/20552173261475519
[2] DiGA Directory of the German Federal Institute for Drugs and Medical Devices (BfArM), entry “levidex” (permanently listed). https://diga.bfarm.de/de/verzeichnis/00752/fachkreise
Journal
Multiple Sclerosis Journal - Experimental Translational and Clinical
Method of Research
Randomized controlled/clinical trial
Subject of Research
People
Article Title
Effectiveness of a digital health application (levidex) on quality of life in people with multiple sclerosis: A pragmatic, randomized controlled trial (LAMONT)
Article Publication Date
6-Aug-2026
COI Statement
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: BM and LB are employees of GAIA AG, the sponsor of the trial and developer of the levidex digital therapeutic. AB is the founder and Chief Executive Officer of NeuroTransData GmbH and has received consulting fees from advisory board/speaker/other activities for NeuroTransData; project management/clinical studies for and travel expenses from Novartis and Servier. KR reports funding by the German Research Foundation and speaker honoraria from the German Nutrition Society. NK, BvG, NG, and KJ-C have nothing to declare. CH has received research grants, speaker honoraria and travel grants from Biogen, Celgene, Genzyme, Merck and Roche, all outside of this work.