Digital health as a support tool for waiting lists in mental health services

Digital health as a support tool for waiting lists in mental health services

The need for mental health support is growing in Europe, and waiting lists are becoming longer as mental health services struggle to meet the demand. But are additional human resources really the answer to these problems, or do we maybe need to search for new solutions?

In Denmark, over 500.000 Danish citizens currently live with one or multiple mental health disorders [1] and approximately half of the Danish population will suffer from a mental illness at least once in their lifetime [2]. 

The need for mental health support is thus at an all-time high. However, the average waiting time to see a psychologist in Denmark is around 16 weeks, and in many cases, patients easily wait up to 20 weeks before their first treatment [3]. 

New studies have found that every 10th person needing psychological support in Denmark decides not to seek help due to the long waiting lists. Amongst young people, this number is even higher: In the last three years, every 5th young person who needed psychological treatment decided not to seek help due to long waiting times [4].

In the UK, waiting times for psychological help are almost equally as long as in Denmark. According to research by the Royal College of Psychiatrists, almost a quarter (23%) of adults suffering from mental illness in the UK face waiting times of over 12 weeks before receiving treatment. Recently, it has thus been reported that individuals with mental illness waiting for treatment increasingly turn to the A&E or even dial 999 in desperate need of help [5].

Research has found waiting lists in mental health services to be “associated with negative psychological and physiological responses such as anxiety and stress”, which usually worsen the longer an individual suffering from mental illness needs to wait for treatment [6]. 

The lack of resources in mental health services is hence a problem that needs to be tackled urgently [2] – but it is unlikely that enough healthcare professionals can be hired in the short term to address this problem. 

This is where digital technologies can play an important role in supporting people waiting for mental health treatment. Digital health solutions for mental health, for instance, offer the potential to screen individuals while they are still on the waiting list. Additionally, digital health solutions can provide individuals with useful tools and psychoeducational material to better manage their mental health while they are waiting to receive care. 

Everyone deserves access to mental healthcare. The integration of digital solutions in healthcare bears huge potential, and it needs to happen timely. There is never a better time to act.
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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. We collaborate with health and social care, pharmaceuticals, and leading researcher worldwide in our endevaours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com.

References:
[1] EN AF OS (n.d.). About EN AF OS. Sundhedsstyrelsen.
http://www.en-af-os.dk/da/English/About-us#:~:text=Statistically%2C%201%20in%205%20Danes,they%20will%20get%20well%20again.

[2] Sundhedsstyrelsen (2022). Fagligt oplæg til en 10-årsplan.
https://www.sst.dk/da/Udgivelser/2022/Fagligt-oplaeg-til-en-10-aarsplan

[3] Kofoed et al. (2022). Millioner til psykologhjælp forbliver ubrugte trods rekordlange ventetider. DR.
https://www.dr.dk/nyheder/politik/kommunalvalg/millioner-til-psykologhjaelp-forbliver-ubrugte-trods-rekordlange

[4] Gjensidige Forsikring (2022). Lang ventetid får mange til at droppe besøg hos læge, tandlæge og psykolog. Ritzau.
https://via.ritzau.dk/pressemeddelelse/lang-ventetid-far-mange-til-at-droppe-besog-hos-laege-tandlaege-og-psykolog?publisherId=9709319&releaseId=13657774

[5] Gregory, A. (2022). Patients turning to A&E as wait times for NHS mental health treatment spiral. The Guardian.
https://www.theguardian.com/society/2022/oct/10/nhs-mental-health-patients-wait-times

[6] Punton, G., Dodd, A.L. & McNeill, A. (2022). ‘You’re on the waiting list’: An interpretive phenomenological analysis of young adults’ experiences of waiting lists within mental health services in the UK. PLoS ONE, 17(3).
https://doi.org/10.1371/journal.pone.0265542​​

The Momentum Trial: How digital tools can support patient-centered care & shared decision-making

The Momentum Trial: How digital tools can support patient-centered care & shared decision-making

In the delivery of mental health services, shared decision-making (SDM) is increasingly becoming more important [1]. SDM can be defined as a collaborative process between patient and health care provider, enabling joint treatment decisions and patient-centered care [2]. Research suggests that in mental healthcare, SDM could “contribute to recovery-oriented care by inviting the patient to have more control and be more involved in their treatment decisions” [2]. 

However, many mental health care providers are still reluctant to incorporate SDM into their treatment offers, as they believe it to be unfit for individuals suffering from severe mental illness, as well as to be time-consuming and thus a burden [3,4]. To overcome these challenges of incorporating SDM into daily practices, healthcare professionals have been encouraged to utilize “tools to support the SDM process” [2]. 

Increased focus has thus been placed on how digital interventions could support SDM in mental healthcare [2]. The Momentum Trial is a study investigating how using a smartphone app as a support tool could help “individuals suffering from schizophrenia-spectrum disorders in an outpatient treatment setting” [5]. 

During the trial, 194 participants were randomized either to receive “specialized early intervention treatment with the Momentum app” (intervention group) or to receive regular treatment without a smartphone app (control group) [5]. The Monsenso digital health solution, consisting of a patient app and a clinical web portal, was used for the intervention group. The Monsenso solution provided tools such as psychoeducational material, daily self-assessments, and action plans in the patient app, as well as patient insights in the clinical web portal [2].

As a primary outcome, it was investigated whether the individuals from the two groups would show a difference in self-perceived patient activation. Patient activation can play an important role in successful SDM processes, as patients who are more active and engaged in their treatment “feel confident when collaborating with their provider, and have the knowledge and skills to manage their condition” [2]. 

As secondary outcomes, it was investigated whether the individuals from the two different groups would show a difference in the self-perceived feeling of hope and optimism, self-efficacy, confidence in communicating with their provider, therapeutic alliance between the patient and provider, feeling prepared to make a treatment decision, and satisfaction with treatment [2]. 

Results were evaluated at baseline, as well as 3 and 6 months post-baseline. Promisingly, the Momentum Trial showed a significant effect of a digital SDM tool on the subjective level of patient activation, confidence in communicating with one’s provider, and feeling prepared for decision-making at the postintervention time point [2]. 

Though no statistically significant effects could be found related to the digital SDM intervention’s effect on working alliance, treatment satisfaction, clinical outcomes, and hope, the results from the Momentum Trial “confirm [the] hypothesis that a digital SDM tool may promote patient activation by supporting the collaborative process between patients and their providers” [2]

Monsenso CEO Thomas Lethenborg says: “The Momentum Trial shows how promising digital tools are in supporting shared decision-making. At Monsenso, we are proud to have been involved in this research project, and look forward to empowering individuals and clinicians even more on the treatment pathway”.
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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. We collaborate with health and social care, pharmaceuticals, and leading researcher worldwide in our endevaours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com

References:
[1] Alguera-Lara, V., Dowsey, M., Ride, J., Kinder, S. & Castle, D. (2017). Shared decision making in mental health: the importance for current clinical practice. Australas Psychiatry, 25(6), 578-582. 

[2] Vitger, T., Hjorthøj, C., Austin, S.F., Petersen, L., Tønder, E.S., Nordentoft, M. & Korsbek, L. (2022). A Smartphone App to Promote Patient Activation and Support Shared Decision-making in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings (Momentum Trial): Randomized Controlled Assessor-Blinded Trial. Journal of Medical Internet Research, 24(10), e40292.
https://www.jmir.org/2022/10/e40292

[3] Hamann, J. & Heres, S. (2014). Adapting shared decision making for individuals with severe mental illness. Psychiatric Services, 65(12), 1483-1486.
https://ps.psychiatryonline.org/doi/full/10.1176/appi.ps.201400307

[4] Waldemar, A.K., Esbensen, B.A., Korsbek, L., Petersen, L. & Arnfred, S (2019). Recovery-oriented practice: participant observations of the interactions between patients and health professionals in mental health inpatient settings. International Journal of Mental Health Nursing, 28(1), 318-329. https://onlinelibrary.wiley.com/doi/10.1111/inm.12537

[5] Korsbek, L. (n.d.). The Momentum Trial: The efficacy of using a smartphone application to support shared decision making for people with a diagnosis of schizophrenia in an outpatient treatment setting. Open Patient data Explorative Network.
https://open.rsyd.dk/OpenProjects/openProject.jsp?openNo=451&lang=da

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Monsenso has signed an agreement with Awakn Life Sciences, a global biotech company

Monsenso has signed an agreement with Awakn Life Sciences, a global biotech company

Monsenso has signed an agreement with, a global biotech company, to support the company’s medical psychedelic treatments. Awakn Life Sciences is a global biotech company that leads the field of psychedelic medicine for the treatment of addiction. In October 2021 commenced the implementation of the Monsenso Digital Health Solution in Awakn Life Sciences clinical practice as a tool for supporting patients throughout their treatment while capturing real-world patient insights to inform clinical decision-making and personalised treatment.

Mental illness and addiction are some of the biggest public health challenges facing the global community.

Nearly one billion people worldwide suffer from mental illness, for which there are too few effective treatments available beyond coping strategies and treating symptoms. With global spending on mental health estimated to reach $16 trillion by 2030 (as measured by lost economic output)[1], it is critical that effective new treatments are developed to address the current gaps. Psychedelic-assisted therapy has emerged as a potential solution to this treatment vacuum. In the early 20th century, these substances were severely restricted and had a negative connotation. Today, however, a growing body of evidence and urgent unmet patient needs have led clinicians and regulators to consider them as a viable treatment option.

Psychedelic-Assisted Psychotherapy represents a paradigm shift in psychiatric treatment

Psychedelic drugs are substances that alter perception and mood and affect various cognitive processes. When used in conjunction with psychotherapy, they can put patients in a temporary state where they can better process memories, emotions, and past traumas[2], allowing for processing that enables subjects to let go of things that have previously troubled them[3]. For the same reason, psychedelic-assisted psychotherapy has shown effective in treating historically difficult-to-treat illnesses[4] and is today considered a promising game-changer in psychiatric treatment[5,6,7].

While psychedelics have spurred great interest in the life science industry, only a few psychedelic companies are currently treating patients in the clinical setting. Awakn Life Sciences launched the UK’s first psychedelic-assisted clinic in Bristol, followed by London and Manchester, offering evidence-based psychedelic therapies for addiction and other mental health indications, and has also opened a clinic in Oslo, Norway with plans to scale across Europe quickly.

In October 2021, Awakn Life Science commenced implementation of the Monsenso Digital Health Solution in its clinical practice to support patients throughout their treatment journey and to capture real-world data to inform clinicians’ decision making for personalised patient support and management.

“We are excited to work with Awakn Life Science to support new treatment options for people who have experienced insufficient treatment results. We look forward to partnering with Awakn Life Sciences and be part of their growth journey” says CEO of Monsenso, Thomas Lethenborg.

Awakn’s CEO, Anthony Tennyson added “There’s such a critical need to provide solutions and hope to people suffering from mental illnesses and addiction. We’re excited to partner with Monsenso to better engage with clients throughout their treatment, gain insights to help inform clinical decisions and improve health outcomes, and generate insights that inform our research and treatment development programs”.

About Awakn Life Science Awakn Life Sciences is a publicly-traded (NEO: AWKN) (OTCQB: AWKNF) biotechnology company with clinical operations; researching, developing, and delivering psychedelic medicine to better treat Addiction. Awakn’s team consists of worldleading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies and enabling technologies to treat Addiction.

About Monsenso Monsenso is an innovative technology company offering a digital health solution for mental health and behavioral disorders. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence and behavioural data. It connects individuals, carers and health care providers to enable personalised treatment, remote care and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment. To learn more visit www.monsenso.com

For additional information contact:
Bettina van Wylich-Muxoll
Chief Marketing Officer
marketing@monsenso.com
Monsenso

Sources:

[1] https://www.weforum.org/agenda/2020/10/mental-health-day-covid19-coronavirus-global/

[2] https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

[3] Jennifer Mitchell, neuroscientist and professor in the departments of neurology, psychiatry and behavioral sciences at the University of California San Francisco.

[4] Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

[5] https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

[6] https://www.scientificamerican.com/article/a-renaissance-for-psychedelics-could-fill-a-long-standing-treatment-gap-forpsychiatric-disorders/

[7] Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

With the rise of patient-centered medicine and accelerated approvals, health technology assessment (HTA) bodies and payers are looking to real-world evidence (RWE) to strengthen evidence packages and reduce uncertainties at the time of launch.

Increasingly, stakeholders are recognizing the importance of RWE that incorporates patients’ real-world experiences in understanding what treatments work, and for whom, in clinical practice.

Real-world evidence is generated through applying data science to real-world data (RWD), or data “relating to patient health status or the delivery of healthcare routinely collected from EHRs, claims, registries, patient-reported outcomes, devices/applications, etc.” Decision-makers are exploring how this evidence can supplement clinical trials and provide additional context on the effectiveness of therapies.

There is some overlap between patient experience data, which provides information about a patient’s experience with a disease or condition, and real-world data (RWD), however, they are not one and the same. For example, patient-reported outcomes (PROs) collected in an electronic health record (EHR) would be considered both RWD and patient experience data, however, lab test results in the medical record would be considered only RWD. As personalized medicine continues to gain traction, decision-makers like ICER, FDA, NPC, EMA, EUNetHTA, and EHDEN are calling for patients’ voices to be included in the drug development and assessment process. Such information – direct input from patients on how they feel and function is often lacking from RWD sources, and FDA and EMA identified such missing data as problematic for interpretation.

We spoke with Ashley Jaksa MPH, Scientific Partnerships Lead, Aetion and Chung Yen Looi, DPhil Partnerships Director, Monsenso, about the evolving landscape of patient experience data and how biopharma organizations can incorporate the patient voice into their RWD and RWE programs.

Q: Ashley, can you tell our readers a little more about what Aetion does? 

AJ: Aetion is a healthcare technology company that uses routinely collected health care data to generate RWE on the safety and effectiveness of medical treatments and technologies. We were founded by Harvard epidemiologists to develop a way to conduct scalable and transparent RWD analyses at the highest level of scientific rigour. Our RWE analytics platform helps biopharma organizations, regulators, HTAs, payers, and other researchers generate RWE to inform decisions on the safety, effectiveness, and value of medical interventions across the product lifecycle. Our platform is data fluent, meaning it can analyze almost any type of RWD, and we often work with our customers and partners to identify the most fit-for-purpose data set for their research question.

Q: Why is the patient experience important for biopharma to understand, and where in the drug development lifecycle is it most important to integrate patients’ voices? 

CL: I think we can all agree that pharma and its stakeholders want to develop safe and effective drugs and bring them to market, to improve patients’ lives. As such, asking patients directly about how a drug impacts their lives is critical. Without the patient voice, we will never know how patients experience therapies in the real world, and how medical interventions could make a meaningful difference to their lives. Capturing and incorporating the patient voice across the product lifecycle can help biopharma companies to better understand the real-world impact of their drug, treatment responders, and meaningful endpoints based on a wider, representative population, in a quick and cost-effective way. 

AJ: Similar to RWE, patient experience data is important in almost all stages of the product lifecycle—not just as a post-marketing exercise. For example, understanding the treatment pathways and patient experiences on first-line therapies can help shape what comparators and outcomes should be captured in future randomized controlled trials to differentiate the drug in the market.

Q: How can incorporating the patient voice improve market access?

CL: Patient voice is a powerful way to demonstrate the impact of a drug on patients’ quality of life to payers and HTA bodies, particularly for cost-effectiveness evaluations. Some biopharma organizations have used PRO measures on daily functioning and health-related quality of life as their primary and secondary endpoints in clinical and real-world studies, while others have directly linked PROs to their drug reimbursement contracts. Patient voice contributions can help biopharma companies differentiate their product from similar drugs for coverage, especially for payers who are tying reimbursement to the value to patients based on outcomes and have longer-term responsibilities for their populations.  Some of the common myths are that “payers don’t care about PRO evidence, PROs only matter if they make it to the label, and that PROs should only be collected in Phase IV.” The facts are that not all payers are alike. Some pay a lot of attention to PRO evidence. Payers will consider all data from pivotal trials, whether or not it is on the package insert, and coverage decisions will be made on pivotal trials, so waiting until Phase IV to collect PROs would be too late.

Q: What are the common barriers in generating high-quality, patient-centric RWE?

AJ: I think the common barriers to generating RWE and patient-centric RWE are very similar; researchers must ensure that the data exists, that the data is capturing the relevant underlying medical concept, and that it is generated in a way that limits bias and confounding. Traditional RWD sources, like claims and EHRs, often have limited patient-centric data. This is a challenge for researchers attempting to incorporate this information into their studies. However, groups like Friends of Cancer Research and data providers like Monsenso are working to ensure this information is being collected. Once it is collected, it is essential to validate that these data and algorithms are actually measuring what we are intending to measure. Finally, researchers must be cognizant of bias and confounding and control for this as much as possible through study design and analytic methods. 

CL: Adding to Ashley’s points, I think data privacy and security, patients’ burden of contributing to research, and standardized methodology to analysis and interpretation are common barriers. It may seem like a no-brainer to ensure that patient data is managed in a secure way, but a recent study showed that almost a third of health apps out there collect patient data without privacy policy, and about one in five data transmissions occurred on insecure communication protocols. Furthermore, as patients are already suffering from their disease or conditions, contributing to research could add to their burden, which is why data capture platforms should be designed in a way that is easy-to-use and that provides valuable insights to patients. Finally, there is a lack of standardization in analysis and interpretation—which is why companies like Aetion are important to ensure that critical questions are answered, data sets are relevant, and standards are followed to derive and present meaningful insights that will inform decision-making.

Q: How can biopharma generate high-quality, patient-centric RWE for decision-makers? 

AJ: In addition to addressing the common barriers mentioned above, we think it is important to follow a principled approach to study design and execution. The main reasons why decision-makers like regulators and HTAs/payers dismiss RWE are due to deficient data selection and insufficient methodology. Following principled epidemiologic methods of selecting fit-for-purpose data, avoiding common methodological mistakes, and ensuring the protocol and results are clearly communicated are essential to ensuring the decision-makers trust the evidence. This planning and execution of RWE studies is not easy; it takes forethought. Biopharma manufacturers should be considering RWE at every stage of the product lifecycle, and proactively planning for how RWE studies will be incorporated into each product’s launch. 

Q. What is the cost-benefit for biopharma of generating patient-centric RWE? 

CL: Relative to the costs of bringing a new drug to market – which could go up to billions of dollars and take over a decade, with limited success ratesthe costs associated with collecting patient-centric RWE is insignificant. In return, patient-centric evidence could provide significant savings and valuable insights as early as possible to ensure that new drugs are truly driven by patients’ unmet needs, that they impact outcomes that matter to patients, and, ultimately, that they have the greatest chance of reaching the market and making a meaningful difference to patients. 

AJ: RWE can provide value for biopharma organizations across the product lifecycle—from eliminating costs typically incurred during clinical trials to accelerating time to market. Using a validated RWE platform can take this a step further, allowing companies to run more efficient, credible studies and reach insights faster than they could with traditional line programming. By ensuring patient-centric outcomes are collected in clinical data sources, then incorporating patient-centric RWE across drug development and commercialization programs, biopharma organizations can unlock insights that deliver value not only for their company but for patients as well. 

Q: Lastly, for our readers who are not familiar with Monsenso, Looi can you kindly tell a little more about what Monsenso does? 

CL: of course, Monsenso is a digital health company that enables patient-centric care and research. We’re a spinout from the IT University of Copenhagen based on the groundbreaking research of Professor Lars Kessing and Dr. Mads Frost on bipolar disorder and depression. We were founded in 2013 and have been listed on Nasdaq First North in Denmark since 2020. Our solution enables pharma companies to collect self-reported and device-generated data directly from patients in a simple, scalable, secure, and cost-effective way. Our cloud-based platform connects patients and investigators via an app and a web portal, respectively, to collect data in real-time across clinical development, post-market studies, and clinical practice to inform decision-making. Our platform can integrate with wearable devices and sensors, and combine with other RWD sources to provide a more holistic view of the impact of a drug on patients’ lives.