Berlin, 20.12.2022 – HelloBetter Sleep has secured approval as HelloBetter’s sixth DiGA (prescription digital therapeutic) by the German Federal Institute for Drugs and Medical Devices (BfArM) and is now included in the DiGA directory. HelloBetter Sleep is the only prescription digital therapeutic that is approved not just for the treatment of nonorganic insomnia (ICD-10 F51.0), but also organic insomnia (ICD-10 G47.0) in Germany. All statutory as well as many private health insurers will cover the costs of HelloBetter Sleep in full, making it available free of charge to 73 million people in Germany. Over the last 14 months, HelloBetter has managed to secure six regulatory DiGA approvals – more than any other company.
Guideline-based treatment of insomnia with clinically tested efficacy
Clinically relevant disorders of initiating and maintaining sleep affect a total of five to ten percent of the population in Germany. In many cases, they remain untreated. As a result, the symptoms often become chronic. On the one hand, many of those affected hesitate to talk to their doctors about their sleep problems. On the other hand, there are few guideline-based treatment options available. The S3-guideline of the German Sleep Society (DGSM) recommends cognitive behavioural therapy for insomnia (CBT-I) as the first-choice treatment method. However, a capacity shortage of licensed therapists results in less than one percent of those affected receiving guideline-compliant therapy.
HelloBetter Sleep is designed to improve the quality of sleep and reduce the burden of insomnia. Based on the current state of scientific knowledge, it teaches effective methods from cognitive behavioural therapy for insomnia treatment in addition to well-founded psychoeducation using texts, videos and audio clips. These include strategies for sleep restriction, stimulus control and sleep hygiene. A digital sleep diary, with which those affected can document and individually adapt their therapy progress, is a central component of the programme.
Even before HelloBetter Sleep was added to the DiGA directory, four randomised-controlled clinical trials in different populations demonstrated the effectiveness of the medical product’s content. In the main HelloBetter Sleep study, nearly 80 percent of patients showed a significant reduction in insomnia symptoms after completing the programme. The positive effects persisted even six months after the end of the programme.
All other studies on the online therapy programme have also shown that different target groups benefit equally from digitally mediated cognitive behavioural therapy and show great effects on the reduction of insomniac symptoms and accompanying rumination.
Low-threshold care option for reducing insomnia distress
Dr. Hanne Horvath, Founder of HelloBetter, who developed the programme for her PhD research, says: “Based on four high-quality randomised-controlled clinical trials, the extent of the underlying evidence for our online therapy programme HelloBetter Sleep is so far unique in Germany. For doctors and therapists, it currently represents one of the most effective options for treating insomnia compliant with current guidelines and in a low-threshold way for patients.”
The internationally renowned sleep physician Prof. Dr. Dieter Riemann, head of the Department of Clinical Psychology and Psychophysiology as well as the Sleep Laboratory at the Department of Psychiatry and Psychotherapy at the University Hospital of Freiburg, has been advocating for years for the integration of digital treatment options into the standard care. He explains: “People with sleep disorders often have to deal with comorbidities. This makes it all the more important to explicitly address insomnia as a disease. ‘HelloBetter Sleep‘ provides much-needed access to CBT-I for a large proportion of those affected. In combination with resourceful differential diagnosis, digital health applications form an important building block in the treatment of insomnia – guideline-based, well-researched through clinical trials and supported by psychologists.”
Individual programme with feedback after each course unit
Within 12 weeks, HelloBetter Sleep guides patients through eight course units and six additional units. Based on the participants’ entries in the diary, the online therapy programme continuously takes into account factors such as sleep efficiency and sleep behaviour. The participants can thus observe their progress, recognise correlations and make changes. In this way, they often experience an increase in terms of their self-efficacy. Specially trained psychologists provide personal, written feedback after each completed course unit. The online therapy programme can also teach various cross-indication techniques such as relaxation exercises and problem-solving strategies to improve overall mental health and sleep.
HelloBetter Sleep can be used as a stand-alone therapy option or as an adjunct to other forms of therapy, bridging waiting time or in aftercare as relapse prevention. The DiGA can be prescribed both in an outpatient setting and as an inpatient treatment within the framework of discharge management.
Here to stay: Prescription Digital Therapeutics
Although October 2022 marked only the second year of public coverage of prescription digital therapeutics in Germany, more and more patients as well as prescribers know about prescription digital therapeutics and actively use them.
In 2021, 14.3% of doctors and therapists had prescribed a DiGA in Germany. In 2022, this number significantly increased to 33.6% who have used a prescription digital therapeutic to treat patients.
Germany’s DiGA model drew considerable attention to universally reimbursed prescription digital therapeutics and other countries, including France and the US, are now building similar frameworks. A few days ago, the new ‘‘Medicaid and CHIP Access to Prescription Digital Therapeutics Act’’ was introduced in Congress. The guidance related to prescription digital therapeutic coverage would help US states leverage existing programmes to expand Digital Therapeutics access for patients covered by Medicaid and State Children’s Health Insurance Program (CHIP).
HelloBetter is one of the world’s leading providers of digital therapy programmes. The company was founded in 2015 by psychologists, Prof. David Ebert, Dr. Hanne Horvath and Dr. Elena Heber. David Ebert, Professor of Psychology & Digital Mental Health Care at TU Munich, is an internationally recognised expert and global pioneer of digital interventions for mental health conditions. HelloBetter prevention and treatment programmes cover eight major mental health issues, including depression, anxiety, insomnia and panic. Six of the company’s digital therapeutics can be prescribed free of charge by doctors and therapists to more than 70 million people with statutory health insurance in Germany. More than 30 randomised-controlled studies on the effectiveness and cost-effectiveness of their therapy programmes have been published in peer-reviewed journals. Globally, no other provider has a comparable body of clinical evidence for the effectiveness of its solutions. HelloBetter is based in Berlin and Hamburg and employs more than 100 people. For more information, please visit www.hellobetter.de