Curebase and Meru Health to Partner on Clinical Research for App-based Mental Health Treatment Program
September 20, 2022
SAN FRANCISCO, Sept. 20, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, today announced it is partnering with Meru Health on a three-year clinical trial to determine the effectiveness of the online mental healthcare provider's 12-week treatment program for reducing depression among primary care patients.
The Meru Health Program is a therapist-guided app-based treatment program for depression, burnout, and anxiety. The program being studied is a 12-week, smartphone-based solution that goes beyond traditional standards of care, including talk therapy and medication.
The study, funded by the National Institute of Health's Small Business Innovation Research (SBIR) 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.
Meru Health and Curebase will begin recruiting for this first phase in early autumn of 2022 and expect to conclude in the spring of 2023. Curebase will be responsible for clinical site selection, patient recruitment, and data collection.
Curebase's decentralized clinical trial (DCT) platform allows clinical sites to streamline the patient recruitment and consent processes prior to launching a clinical study. Once a trial is underway, the Curebase platform optimizes patient data capture, whether it's generated from a patient site visit or remotely through a telemedicine session.
Curebase enables patients to take part in the Meru Health research within the context of their primary healthcare. For example, during an annual physical a clinician may assess a patient's mental health, and if symptoms are indicative of a person battling depression or general life anxiety, the clinician then may refer a patient they identify as potentially qualifying for this study over to this program. Should the patient successfully clear the screening and clinical intake process, they will be instructed to download the app and proceed with enrollment.
After analyzing results and processes that were established during the proof-of-concept study, Curebase and Meru Health will collaborate on a randomized controlled trial (RCT) that will include 300 participants and eight primary care clinics across the U.S.
During the RCT phase, Curebase and Meru Health will collect and analyze ePROs or 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.
"Meru Health's smartphone-based mental health program shows tremendous potential for bringing effective and accessible treatment to the growing population of depression and anxiety patients," said Curebase CEO and founder Tom Lemberg. "We're excited to be working with Meru Health on clinical research that has the potential to benefit millions of Americans."
In addition to on-demand clinician support, behavioral mindfulness, and biofeedback practices, Meru Health integrates sleep, nutrition, and social support into its treatment framework. This new app includes built-in functionality for collecting biofeedback data such as heart rate variability through a device attached to the participant's earlobe.
"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," said Kristian Ranta, founder and chief executive officer of Meru Health. "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."
Nearly one in five U.S. adults lives with mental illness and only half of Americans with mental health issues receive treatment, according to the National Institute of Mental Health. Roughly $280 billion was spent on mental health services in 2020.
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.
About Meru Health
Meru Health is setting the new standard in mental healthcare with the most comprehensive online solution that combines licensed therapists and psychiatrists, a smartphone-based treatment program, biofeedback training, anonymous peer support, and habit-changing activities for sleep, nutrition and more. The company is committed to evidence-based care and has published groundbreaking clinical outcomes with Stanford, Harvard, and UC Davis that show promising clinical effectiveness and lasting results that offers a convenient, accessible, side effect-free mental health treatment option in contrast to the standard of care in the U.S. today. Meru Health partners with major health insurance providers like Cigna, Humana and Moda Health, as well as leading businesses who want to provide best-in-class mental health care for their employees or members. For more information, visit www.meruhealth.com and follow us on LinkedIn, Facebook, and Twitter.
Amendola Communications (for Curebase)