DTx Product Profile

HelloBetter® Sleep

Product Highlight

Condition targeted:

Insomnia

How it works:

HelloBetter Sleep is a digital therapeutic program aimed at reducing the severity of insomnia symptoms. This digital intervention was developed and evaluated by a team of scientists and psychotherapists and is based on the well-established methods of cognitive-behavioral therapy for insomnia (CBT-I). The program was extensively studied and clinically proven in four randomized controlled trials. 79.7% of patients showed a significant reduction in insomnia severity after completing the program.

Impact:

Clinically proven to significantly reduce insomnia severity and improve sleep efficiency, sleep quality, depressive symptoms, rumination, and worrying.

Product Overview

Medical condition:

HelloBetter Sleep is designed for adults who meet the criteria for the following F51.0 Nonorganic insomnia; G47.0 Disorders of initiating and maintaining sleep [insomnia].

Target patient population:

Individuals who wish to overcome poor sleep and recover from insomnia.

What to expect:

HelloBetter Sleep is a 12-week program that is structured into 8 units. Each unit takes approximately 45-60 minutes to complete.

Note: for more information, please visit https://hellobetter.de/en/online-courses/sleep/

Clinical Overview

Indications for use:

HelloBetter Sleep is a digital therapeutic aimed at reducing the symptom severity of insomnia.

Outcomes:

Research demonstrated that 79.7% of participants experienced a significant reduction of insomnia symptoms after completing the program. After 6 months, 42.2% of the participants were still symptom-free.

Directions:

HelloBetter Sleep delivers a guideline-based treatment for insomnia by empowering patients with self-led Cognitive Behavioral Therapy for Insomnia (CBT-I), the first-line treatment for insomnia. HelloBetter Sleep translated the CBT-I framework and methods into a digital program, teaching guideline-based strategies for sleep hygiene, bedtime reduction, stimulus control, relaxation techniques, behavioral activation, strategies for dealing with dysfunctional thoughts, rumination and relapse prevention. The exercises are taught throughout the units and can be integrated into everyday life. Goals are set and formulated in such a way that they are specific, realistic, and achievable. In addition to the course units and practical exercises, the program grants access to an online journal, a companion app, and recurring symptom checks to record, monitor, and evaluate one’s own progress.

Risks & warnings:

HelloBetter Sleep may not be suitable for people without internet, wifi, or a mobile or desktop device. This digital therapeutic was developed and evaluated on adults aged 18 years and older.

Place in therapy:

HelloBetter Sleep can be used independently or as a complement to ongoing medical and/or psychotherapeutic treatment. The therapy program is also suitable for bridging the waiting time for a place in psychotherapy and as support after treatment has been completed.

Product Access

Product description:

HelloBetter Sleep is accessible through mobile and web.

Prescription status:

A prescription is not required. In Germany, it has been listed as a digital health application (‘DiGA’), meaning that a diagnosis or prescription leads to universal reimbursement. However, individuals without a diagnosis can access the program through self-pay, or via their care provider.

Patient access:

Eligible users can access the program online, and download the HelloBetter companion app on iOS or Android devices.

Use of this product requires access to:

Provider access:

Full provider access is given if providers (e.g. clinic) purchase HelloBetter through their ‘Software-As-A-Service’ offering, which allows providers to add patients, choose products for patients, guide the patients through the product via messages, chat, and regular feedback, etc. Patients may choose to export their information via a downloadable file to certain healthcare providers. This file contains all relevant information on patient progress and symptoms and can be integrated with major EHRs going forward.

Coverage options:

In Germany, HelloBetter Sleep is eligible for prescription and covered by statutory health insurance in Germany – making it available free of charge to over 73 million people.

Product availability:

HelloBetter® Sleep is available in:  

Unique Features.

HelloBetter Sleep is the first DTx to treats both nonorganic and organic insomnia, to enter the standard of care in Germany.

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

 

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