The companies are partnering on a 3 year long trial to measure the effectiveness of Meru’s treatment
There are many companies in the mental health space right now, all vying for dollars and attention, so all of them need to have some kind of differentiation; what Meru Health believes sets itself apart is its approach, which combines science and technology.
The company’s 12-week program includes therapist and psychiatrist support, anonymous peer support, meditation practices, habit-changing activities for sleep and nutrition and a biofeedback training device. The idea is to actually be able to measure the effectiveness of its treatment program through clinical evidence.
To that end, this week Meru announced a partnership with Curebase to conduct a three-year clinical trial that will measure if it the company’s solution is actually reducing depression among its members.
The study, funded by the National Institute of Health’s Small Business Innovation Research program, will be split into two phases: in the proof-of-concept phase, 15 patients will undergo Meru Health’s treatment program, while another 15 will receive treatment as usual, such as face-to-face therapy, antidepressants, or some combination, under the direction of their primary care physician.
Founded in 2017, Curebase provides virtual and hybrid site capabilities, along with a software platform geared toward both patients and sponsors.
With Curebase, patients can look up a clinical trial, learn about the risks, the benefits, what the treatment is, and what it will mean to participate. They can call one of the company’s virtual coordinators who can give them more information. If they decide they want to be in the trial, patoents can answer eligibility screeners, connect medical records, schedule a telemedicine call a coordinators to go through some questionnaires together, and provide consent.
All appointments, both in person with a local healthcare provider or at home, can be booked directly through Curebase. The company will also engage with patients for the rest of the clinical trial, with periodic reminders, as well as to pay them for their participation.
On the other side, Curebase will help the sponsors of the clinical trials, which can be a pharma company, a biotech company, or a medtech company, with finalizing the design of their protocol to make it more patient-centric. That includes configure the software platform for them, as well as recommending community sites they can use.
Curebase will be responsible for clinical site selection, patient recruitment, and data collection for Meru’s clinical trial.
Meru Health and Curebase will begin recruiting for this first phase of the trial in early autumn of 2022 and expect it to conclude in the spring of 2023. After they analyze results and processes, the two companies will collaborate on a randomized controlled trial that will include 300 participants and eight primary care clinics.
During the RCT phase, Curebase and Meru Health will collect and analyze electronic patient-reported outcomes. After participants complete treatment, researchers will track their progress for up to a year to determine whether there are sustained patient benefits from the Meru Health program when compared to standard treatment as usual.
“Too many people who are struggling with mental health issues also struggle with gaining access to effective treatment and our solution was created to help these people,” Kristian Ranta, founder and chief executive officer of Meru Health, said in a statement.
“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.”
(Image source: meruhealth.com)
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