Berlin/Hamburg, 19 October 2021 – The digital therapeutic HelloBetter Stress and Burnout has been permanently approved by the Federal Institute for Drugs and Medical Devices (BfArM) as a Digital Health Application (DiGA) and thus is available by prescription. It is the world’s first and so far only prescription digital therapeutic for the treatment of burnout symptoms.
- The digital therapeutic is aimed at people with occupational stress, exhaustion, the feeling of being burnt out or persistent stress in their everyday life.
- Participants are accompanied by qualified psychologists.
- Eight clinical studies have proven its effectiveness in reducing stress, depressive symptoms, insomnia and symptoms of exhaustion.
- When prescribed by doctors or therapists the costs for the digital medical device are covered by all statutory health insurance companies.
According to Gallup, about one-third of people around the world reported feeling stressed and worried. The effects of the Corona pandemic are adding fuel to the fire: fear of infection, home office, additional childcare responsibilities – doctors have been observing rising levels of psychological stress. In the US, 75% of workers have experienced burnout, with 40% saying they have experienced burnout specifically during the pandemic. Recently, burnout was also recognised by the WHO within the framework of the International Classification of Disease. Now, with HelloBetter Stress and Burnout, the world’s first digital health intervention for the treatment of burnout symptoms has been integrated into routine care in Germany and can thus be prescribed by doctors and therapists nationwide.
This approval was made possible by a new law, the so-called digital care act, which is designed to catalyse the digital transformation of the German health care system. in order to be listed, the German regulatory body for pharmaceuticals (BfArM) conducts a rigorous review of the scientific evidence for the effectiveness of a given product and other relevant criteria such as data protection and security. When a digital medical device meets all of the criteria, it is added to a central database of digital health applications. Listed therapeutics can be prescribed by physicians and psychotherapists and will then be reimbursed by all of Germany’s statutory health insurance providers.
Henrik Matthies, Managing Director of the Health Innovation Hub, the innovation unit of the Germany’s Ministry of Health explains: “The Digital Care Act allows us in a streamlined process to bring innovative, safe and scientifically proven digital treatments into routine medical care, for the benefit of both patients and in the long run also that of payers.”
HelloBetter Stress and Burnout is a web application with an optional companion app, which – based on Cognitive Behavioural Therapy – offers fully-fledged digital burnout therapy online. Specially trained psychologists accompany patients during the therapy course, providing feedback and support in the event of any crises that may arise.
The twelve-week course consists of seven course units with a workload of about one hour each. In these units patients learn how to reduce the effects of stress through – among others – psychoeducation, behavioural activation and mindfulness techniques. After completion of each course unit, HelloBetter psychologists provide written feedback based on the participants’ input.
Clinically proven effectiveness
HelloBetter was founded as a spin-off of Leuphana University of Lüneburg, Germany.
An interdisciplinary team of therapists and research scientists developed and evaluated the interactive programme under the leadership of Dr. Dipl.-Psych. Elena Heber, co-founder of HelloBetter, in more than five years of research.
The so-called “positive care effect” of the DiGA HelloBetter Stress and Burnout was proven by a randomised controlled trial (RCT) with 264 participants, which was conducted at Leuphana University of Lüneburg. The results show that the participants in the therapy course achieved a very strong reduction in stress in the sense of the statistical convention “Cohen’s d” (effect size) as well as a reduction in depressive symptoms, anxiety, insomnia and emotional exhaustion, among other things, and were able to increase their quality of life and commitment at work. Compared to a waiting control group with access to the standard of care, 61.4% of the participants showed a reliable clinical improvement in their stress levels immediately after the course. After six months that number had even risen to 77.3 % of the participants who showed such an improvement. In a total of seven further randomised-controlled studies with over 2000 participants, the results could be replicated with different target groups in a wide variety of contexts. One finding was that people with particularly high levels of stress, depressive symptoms and high levels of emotional exhaustion also benefited from HelloBetter Stress and Burnout. No other comparable intervention worldwide has been scientifically evaluated more extensively and demonstrated better results.
Barr Taylor, Professor for Psychiatry (Emeritus) at Stanford University and one of the world’s pioneers in digital mental health research maintains: “The digital therapeutic programs developed by HelloBetter have proven to be effective in a number of clinical trials. These programs provide easy access to evidence-based treatment without any waiting time, help people to deal with their mental health struggles and might even reduce mental health treatment costs. The reimbursement of HelloBetter Stress and Burnout by all German public health insurance companies is a huge step forward for the digital health scene worldwide, and positions Germany to be at the forefront in providing effective digital therapeutics to treat mental health problems.”
David Ebert, Professor of Psychology and Digital Mental Health Care at the Technical University of Munich and founder and chief scientist at HelloBetter, explains:
“The need for psychological care is enormous – and has increased even more since the beginning of the pandemic. HelloBetter Stress and Burnout can make an important contribution to providing timely and effective support to those affected and help payers reduce burnout-related costs. It is a low-threshold form of care that supports people in need with evidence-based strategies that empower people to deal with their problems on their own. This is exactly what many people want.”
More information on the digital therapeutic HelloBetter Stress and Burnout:
- Official DiGA directory: HelloBetter Listing (German)
- HelloBetter English Website: HelloBetter Homepage
- HelloBetter Scientific Evidence: HelloBetter Research
- HelloBetter Newsroom: HelloBetter Newsroom
HelloBetter is among the world’s leading providers of therapy courses. The company was founded in 2015 by psychologists Prof. Dr. David Ebert, Dr. Hanne Horvath and Dr. Elena Heber. David Ebert, Professor of Psychology & Digital Mental Health Care from TU Munich, is an internationally recognised expert and global pioneer of digital interventions for mental health conditions. HelloBetter prevention and treatment courses cover eight major mental health issues ranging from depression, anxiety or insomnia to vaginismus and chronic pain. More than 30 randomised-controlled studies on the effectiveness and cost-effectiveness of their therapy courses have been published in peer reviewed journals. No other provider globally has a comparable body of clinical evidence for the effectiveness of its solution. The company is based in Berlin and Hamburg and employs more than 70 people. Further information is available at www.hellobetter.de