On Tuesday, Curebase announced a three-year clinical trial partnership with Meru Health, the study looking at the effectiveness of the latter’s 12-week treatment program, developed to reduce depression in primary care patients.
According to the National Institute of Mental Health (NIMH), almost 1 in 5 adults in the US live with a mental health disorder and only half of those have access to treatment.
The Meru Health program is a therapist-guided, app-based treatment plan for depression, and anxiety and burnout as well. A Smartphone-based solution that stretches beyond talk therapy and medication, it aims to provide a new, digital standard of care.
The study is funded by the National Institute of Health’s Small Business Innovation Research (SBIR) program and will be divided into two phases. The first is the proof-of-concept phase.
Meru Health and Curebase commence recruitment for this phase this autumn, wherein 15 patients will undergo the app-based 12-week program from the comfort of their own homes and another 15 will undergo traditional treatment, such as face-to-face therapy, antidepressants, or a combination of the two, under the supervision of a primary care physician. It is estimated the first phase will conclude next Spring.
The Meru Health app provides on-demand clinician support and behavioural mindfulness techniques – in addition to integrated sleep, nutrition, and social support – without the need for on-site attendance. Biofeedback data, such as heart rate variability, is a further feature and is enabled by a device attached to the earlobe of participants.
Founder and chief executive officer of Meru Health, Kristian Ranta said: “Curebase is an ideal partner for us because the company’s DCT platform and support services allow us to focus on the clinical aspects of these trials, while treating participating patients at a variety of locations.”
Curebase’s decentralized clinical trial (DCT) platform permits streamlining of both patient recruitment and consent processes prior to launch of a clinical study, as it operates within the context of primary healthcare.
During an annual physical, for instance, a patient might be referred by their doctor as a qualifying candidate for the Curebase/Meru Health study, should they exhibit signs of depression or anxiety. A screening and clinical intake process would then follow and, if successful, the patient would be instructed to download the app and enrol.
Curebase is to be responsible for these aspects under the partnership, as well as clinical site selection and data collection, capture of which the DCT optimises from either a patient site visit or telemedicine session.
The second phase will consist of a collaborative randomised controlled trial (RCT) of 300 participants and eight US primary care clinics, using collected and analysed electronic patient-reported outcomes (ePROs). It will track patient progress for up to 12 months after the program has finished, to ascertain any sustained benefits.
CEO and founder of Curebase, Tom Lemberg said the program “shows tremendous potential for bringing effective and accessible treatment to the growing population of depression and anxiety patients. We’re excited to be working with Meru Health on clinical research that has the potential to benefit millions of Americans.”
Set up five years ago, in May 2022 Curebase raised $40 million in Series B financing – taking its total funding to $59 million. At the time, Lemberg stated that his company’s model aims to “speed up enrolment into trials, improve diversity […] and achieve cost savings”.
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