Start of Patient Recruitment for the Phase V Project

Start of Patient Recruitment for the Phase V Project

Copenhagen, Denmark 

We are delighted to share an update on PhaseV, a national cross-sector innovation effort, supported by Innovation Fund Denmark, that aims at advancing decentralised, real-world clinical studies in Denmark.

ABOUT THE PROJECT

PhaseV is developing a new, digital model for running clinical studies that brings monitoring closer to patients and clinicians over longer periods. It collects patient-generated real-world data via questionnaires and connected devices, presenting insights to patients in an app and to clinicians in a web portal, both developed by Monsenso. The programme will pilot three proof-of-concept studies in obesity, diabetic foot ulcers, and chronic spontaneous urticaria.

Recruitment has begun for the obesity research arm of the PhaseV project

Steno Diabetes Center Aarhus is recruiting participants for a 24-week, fully online study. Participants receive personal guidance and support from clinical dietitians while data are gathered digitally at home using a smartwatch, connected scale, and the study app.

The primary objective of this study is to assess the feasibility of enrolling participants with overweight or obesity into weight management programs within a decentralised clinical trial (DCT) framework, and to evaluate the ability to reliably monitor body weight in such a setting. In addition to feasibility, the study seeks to determine whether relevant health gain parameters can be accurately captured by leveraging participant compliance data obtained through digital device usage. This approach aims to provide insight into both adherence and the quality of data collection in a decentralised environment. Another important objective is to investigate the impact of weight management interventions on health outcomes over the course of the study. By analysing longitudinal health data collected remotely, the research intends to evaluate the effectiveness of these programs in producing measurable improvements. Finally, the study includes an evaluation of participants’ reported satisfaction with the devices used, as well as their perspectives on the overall feasibility of the decentralised setup. Incorporating these user-reported outcomes ensures that the study not only addresses clinical effectiveness but also considers the practical and experiential dimensions of trial participation. Taken together, these objectives reflect a comprehensive effort to explore both the scientific and operational dimensions of conducting weight management research through decentralised clinical trial methodologies.

If the project may be relevant to citizens or patients you support (exclusively in Region Midtjylland), please share the project page and participation form

cross-sectorial COLLABORATION

The consortium is led by Monsenso and includes partners across academia, healthcare, industry, and innovation: Aarhus University, Research Unit for General Practice (FEAP), Bispebjerg Hospital, Steno Diabetes Center Aarhus, Aarhus Municipality, the Danish Technological Institute, the Alexandra Institute, the Copenhagen Institute for Futures Studies, Danish Life Science Cluster, Novo Nordisk, and Novartis.

PhaseV aims to deliver a scalable digital platform for effective decentralised recruitment, continuous data capture, and phase-V style real-world studies that can strengthen patient care and decision-making.

For more information about the project and its progress, visit the PhaseV website or the Danish Life Science Cluster project page, or follow Monsenso on LinkedIn.


 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

Monsenso completes ISO 27001 surveillance audit

Monsenso completes ISO 27001 surveillance audit

Copenhagen, Denmark 

Monsenso is pleased to announce the successful completion of its ISO 27001 surveillance audit, further validating our commitment to world-class information security.

ISO 27001 is the leading international standard for information security management systems (ISMS). It ensures that organisations implement comprehensive processes to protect sensitive information, intellectual property, and third-party data in accordance with globally recognised best practices.

The successful audit confirms that Monsenso maintains robust data protection standards, ensuring the confidentiality, integrity, and availability of sensitive health data collected and processed through our platform.

“Data security is a cornerstone of trust in digital health. This audit reaffirms that Monsenso continues to protect user data at the highest level, giving patients, clinicians, and partners the confidence they need to embrace digital mental health solutions,” says Thomas Lethenborg, CEO at Monsenso.

By combining rigorous information security practices with high-quality, clinically validated digital solutions, Monsenso remains committed to supporting healthcare providers and researchers with technology that is not only innovative but also safe and trustworthy.

For additional information, please contact:

Nanna Iversen

Chief Operating Officer

iversen@monsenso.com

+45 27267120


To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

Monsenso CEO Thomas Lethenborg Named Enthusiast of the Year by Danish Life Science Cluster

Monsenso CEO Thomas Lethenborg Named Enthusiast of the Year by Danish Life Science Cluster

Copenhagen, Denmark 

We are proud to share that Thomas Lethenborg, CEO of Monsenso, has been recognised as “Enthusiast of the Year” in the Danish Life Science Cluster Awards 2025.

The award highlights Thomas’s visionary leadership and his dedication to fostering innovation and collaboration across the healthcare ecosystem. Together with Monsenso, he has been a first mover in digital mental health solutions, bridging public and private sectors and driving evidence-based approaches to support people living with mental health challenges.

The recognition also extends to Monsenso’s ongoing contributions to major innovation projects such as PhaseV Health Studies, PERSONAE, and MentBest, which aim to create meaningful, data-driven solutions for mental health and wellbeing.

Read the full announcement on the Danish Life Science Cluster website here.


To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

Mental health app could help prevent depression in young people at high risk

Mental health app could help prevent depression in young people at high risk

A cognitive behavioural therapy (CBT) app, based on Monsenso’s digital health platform, has been found to significantly prevent increases in depression in young people who are at high risk – and could be implemented as a cost- effective, large-scale public mental health measure.

Globally, concern is growing about the high and steadily increasing rates of anxiety and depression in young people. Effective and scalable ways of preventing poor mental health in this group are needed, and digital tools such as mobile apps have been proposed as part of the solution.

Whilst there is emerging evidence for mental health apps being effective in treating anxiety and depression, the EcoWeB project led by the University of Exeter is the first to rigorously test a mental health app on such a large scale across four countries. Two linked papers published on Oct 4 in Lancet Digital Health report the results of the ECoWeB-PREVENT and ECoWeB-PROMOTE trials, which ran concurrently in the four-year study funded by Horizon 2020. Critically, these studies found that a CBT self-help app based on Monsenso’s digital health platform can protect vulnerable young people against depression.

Professor Ed Watkins from the University of Exeter led the project and said: “For young people with elevated risk, our findings suggest the CBT app does have a preventative effect on depression and could have a public health benefit. Participants’ quality-of-life measures were better, and their reported work and social functioning was better.

“However, we also found that it’s hard to make improvements in young people who are basically doing okay. Our findings add to the evidence that prevention for depression works best when we identify and select individuals who are more at risk, rather than take a more universal approach. This identification could be done by an online self-screening process or through professional referral.”

CEO Thomas Lethenborg at Monsenso said: “We are happy with the outcomes of this study and see great potential for our platform based on this. It shows that our platform can be used to deliver cost-effective guidance and interventions at scale and that it can be used to enable large-scale, international decentralised trials collecting continuous real-world data from participants.”

The aim of the EUR 4-million project was to test the effects of mobile apps in preventing depression and promoting mental well-being for young people aged 16 to 22. In one of the largest studies of its kind, 3,700 young people took part across the UK, Germany, Belgium, and Spain and were allocated into two trials based on their emotional competence abilities at the start of the study. That resulted in 1,200 young people with reduced emotional competency scores that confer increased risk for depression such as increased worry and overthinking going into one trial focused on prevention, whilst 2,500 without such risk went into the other trial focused on wellbeing promotion.

Those two groups were then randomised in equal numbers to three different apps developed by the project based on Monsenso’s platform. There was a self-monitoring app where people can report their emotions every day, a self-help app that provided personalised training in emotional competence skills, and a self-help app based on CBT principles. Participants were then followed up at three months and 12 months to see how their wellbeing and depression symptoms changed.

The trials found the CBT app prevented an increase in depression, relative to self-monitoring in the higher risk sample, but that there was no difference between any of the interventions in their effects for the lower risk sample.

Professor Ed Watkins at University of Exeter said: “Our results suggest that even when young people used the self-help app just a few times, there was a small but meaningful benefit. Because the app is scalable to large numbers of people in a cost-effective way, these effects have potential value as a public health intervention, within a broader portfolio of digital and in-person services and interventions. Next steps are to identify the active ingredients of the app that were beneficial and to improve engagement and ongoing use of these elements.”

The project involved 13 different partners, including two commercial companies – digital health platform provider Monsenso and German voice analysis company audEERING. The University of Exeter (UK), LMU Munich (Germany), Ghent University (Belgium), and Universitat Jaume I (Spain), were the main treatment development and trial sites. Meanwhile, the University of Oxford led on the qualitative analysis.

The studies are titled ‘Emotional competence self-help app versus cognitive-behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial‘ and ‘Emotional competence self-help mobile phone app versus cognitive behavioural self-help app versus self-monitoring app to promote mental wellbeing in healthy young adults (ECoWeB PROMOTE): an international, multicentre, parallel, open-label, randomised controlled trial’, and both are published in Lancet Digital Health. This work was supported by European Union Horizon 2020 Personalised Medicine SC1-PM-07–2017 grant agreement 754657.


Click the button below for more information about the Monsenso solution.

Carelink and Monsenso partner to deliver digitally enabled nationwide mental health services

Carelink and Monsenso partner to deliver digitally enabled nationwide mental health services

Carelink Nærhospital and Monsenso entered into a partnership and expect to deliver the first digitally supported mental health services in January 2024. 

Carelink Group, Denmark’s largest private health and welfare services group, and Monsenso, a leading provider of validated digital mental health solutions, have entered into a groundbreaking partnership that will redefine the way mental health services are delivered for the benefit of patients, healthcare professionals, and the healthcare sector as a whole.

Mental health is a crucial part of our society, and the need for innovative solutions to address challenges in this area has never been bigger. Carelink’s extensive experience in delivering high-quality healthcare services, combined with Monsenso’s advanced digital health solution, has the potential to create lasting value for both the healthcare sector, the work of healthcare professionals, and particularly for patients. The partnership aligns with the Danish government’s initiatives in psychiatry and the recently presented Finance Act for 2024.

Key points in this partnership include:

  1. Highly scalable digitally supported healthcare services: The partnership creates an innovative foundation that integrates traditional mental health services with advanced digital solutions. This comprehensive offering will provide individual users with tools for digital self-help, self-monitoring and effective remote clinician follow-up before, during, and after treatment.
  2. Addressing workforce issues: The shortage of qualified personnel in mental health is a challenge. This partnership aims to alleviate the problem by optimising resources and leveraging technology to expand the reach of healthcare professionals, enabling them to serve a larger number of patients.
  3. Reduced waiting times: Long waiting lists for mental health services are a significant problem nationwide. The collaboration will streamline the process and offer timely assistance through a combination of digital solutions and remote follow-up, ensuring that patients receive the support they need promptly.
  4. Improved patient experience: Patients will experience a more patient-centered and convenient approach to assessment and treatment for mental disorders. The partnership will enhance the patient experience, promote patient involvement, and provide effective follow-up, support, and treatment.
  5. Quality treatment: The combined offering will promote better treatment outcomes, as patients will have the necessary tools and support for digital self-help, self-monitoring, and effective remote follow-up. This is expected to lead to improved quality of life, more efficient processes, and a reduction in relapses.

“We have entered into this partnership to meet the pressure on psychiatry and the healthcare sector today. We aim to create a Digital First but not Digital Only offering, making waiting lists, assessment, and treatment processes more patient-centric. We believe we can achieve this by leveraging the latest clinically validated technologies to effectively follow up on treatment – also at a distance and in patients’ own homes,” says Maria Pico Almsgaard, CEO of Carelink Nærhospital.

“The potential in the partnership to create easily accessible, nationwide offerings is significant. Far too many patients are waiting for treatment and not provided with the effective, digitally supported offerings that they would like. Better assistance for children and young people, as well as digital offerings, is a priority for the government, and that’s why we have also started with digitally supported offerings for children and young people, but with new pathways continuously added,” says Thomas Lethenborg, CEO of Monsenso.

Click the button below for more information about the Monsenso solution.

Monsenso signs new agreement with a leading pharmaceutical for a real-world data project in Denmark

Monsenso signs new agreement with a leading pharmaceutical for a real-world data project in Denmark

Monsenso signs a new agreement with a leading pharmaceutical company to implement its solution for decentralised patient-centric real-world data collection in a chronic disease area.

Under the new agreement, Monsenso will deliver and support real-world patient data collection for a decentralised patient-centric study expected to take place over the next 12 months.

The agreement and the solution delivered build on Monsenso’s existing platform, which will be customised to support the specific study and the disease of the patient group. It also includes developing new features to support the patient-centric real-world data study, which will position Monsenso’s solution even stronger in the future.

“With this project, we hope to contribute to getting deeper learnings on which treatments work for which patients by continuously engaging and collecting real-world data from patients.

The potential of this engagement is significant – both with the pharmaceutical company itself across other geographies and disease areas as well as with similar companies.” says Thomas Lethenborg, CEO of Monsenso.

The project comes one year into the start of the PhaseV research project, where Monsenso further develops its solution to fully support decentralised real-world data studies and trials in collaboration with leading pharmaceutical companies and research institutions.

Click the button below for more information about the Monsenso solution.