Small Biz Grant Funds Mental Health App Clinical Trial

(Victoria Borodinova, Pixabay. https://pixabay.com/photos/cover-your-face-with-your-hands-hide-6599123/)

10 May 2022. National Institute of Mental Health is funding a clinical trial to evaluate a home-based mobile app that works online with a clinician to treat depression. Meru Health in San Mateo, California is the recipient of a $2 million grant from NIMH, part of National Institutes of Health, for the three-year assessment of the company’s solution, with the agency recently awarding $750,000 for the first year of the project.

Meru Health says it uses an holistic mental health therapy approach in a mobile app that combines guidance from a licensed therapist with exercises to learn more productive behaviors and habits, biofeedback such as sleep and heart rate variability, and an online anonymous support group. The 12-week program, says the company, is coordinated from the outset with the participant’s primary medical care provider and can call on a psychiatrist for medication oversight if needed. Meru Health says its app and home-based approach maximizes privacy for people with depression, a disorder that often stigmatizes patients.

The company says a home-based therapy using online technology is needed to keep up with a growing demand for effective mental health services that in many communities is outstripping the supply of licensed clinicians. “We’re currently experiencing a national mental health crisis,” says Meru Health research director Nicholas Peiper in a company statement released through Cision. He adds, “Our program attempts to overcome many barriers to care while making sure that even more people get better and stay better long-term.”

Reductions in depressive and anxiety symptoms

Meru Health cites research showing eight of 10 participants in its program show signs of improvement or recovery. A study in the Journal of Medical Internet Research in June 2021, gives results assessing an eight-week version of the program among a group of 20 older adults, average age of 61. The results show three-quarters of the group completed at least seven of the eight weekly sessions, with reductions in depressive and anxiety symptoms from before to after the program. Nearly half (45%) reported clinically meaningful improvements in depressive or anxiety symptoms. The study had no control or comparison group.

The NIMH grant funds a proof-of-concept assessment of the Meru Health program in advance of a clinical study. Meru Health plans to refine and optimize its app and supporting materials, and test its screening, referral, and enrollment processes to prepare for the trial. The early-stage clinical trial itself plans to enroll some 300 adults with depression at multiple sites, with participants randomly assigned to testing groups to evaluate the program’s effectiveness. The company expects findings from the trial to help guide the design of later studies and provide guidance for further program adjustments.

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. Most SBIR grants are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. In this undertaking, the two phases a combined into a single project.

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