# HYBRID TYPE 1 EFFECTIVENESS-IMPLEMENTATION TRIAL FOR PRIMARY CARE DEPRESSION SCREENING AND REFERRAL TO A REMOTE DIGITAL MENTAL HEALTH CLINIC

> **NIH NIH R44** · MERU HEALTH MEDICAL, P.A. · 2022 · $749,689

## Abstract

ABSTRACT
The global burden of depression is staggering: Affecting an estimated 7 to 10% of the adult U.S. population in
any given year, depression’s high rates of comorbid conditions and association with impaired functioning and
disability costs the U.S. approximately $200 billion per year. Issues continue to plague screening, recognition,
and treatment for depression in primary care settings. Patients with depression are recognized as such, less
than half of the time in the U.S, with 49.2% sensitivity and 81.1% specificity for accurately identifying patients
having a current major depressive episode. Treatment for depression usually begins with primary care providers
prescribing antidepressants and use of collaborative care models, however, patients experience many barriers
to these treatments such as high costs, embarrassment in seeking help, and long waits for appointments. These
treatments have also been shown to have only a short-term effect, and patients continue seeking treatment
without finding an accessible and effective solution to alleviate their depressive symptoms.
Meru Health Medical, P.A. developed a complete and clinically proven treatment program for depression,
anxiety, and burnout with long-lasting outcomes. The Meru Health Program (MHP) is a 12-week, mobile app-
based online digital mental health clinic overseen by a licensed clinical therapist and a psychiatrist. The delivery
of the MHP seeks to overcome many of the barriers that can hinder the receipt of mental health services such
as improved access and less stigma. This SBIR Direct-to-Phase II application is aimed to conduct a multi-site
Hybrid Type 1 Randomized Control Trial (RCT) of the MHP among adults who screen positive for depression in
primary care to prepare for the program’s rapid dissemination. This application proposes a proof-of-concept
study to develop and optimize the study materials, test the screening, referral, and study enrollment procedures
in preparation for a 300-patient multisite RCT. Following, a multistakeholder process evaluation of the delivery
of the MHP intervention will be conducted to guide the set-up of subsequent studies and to better understand
contextual factors for implementation.
The study design allows simultaneous testing of the effectiveness of the clinical intervention on relevant
outcomes while observing and gathering information on implementation which is requisite for the program’s rapid
dissemination. The unique benefit of the MHP is in its discreet administration to patients with the treatment
modalities and approaches utilized in the program, validated by high quality studies showing significant proof of
efficiency. Meru Health Medical, P.A. is committed to cutting-edge research conducted with integrity as a way to
continuously improve the MHP. This application will establish the feasibility of referral to the MHP via direct
screening in a primary care setting, benefiting the high percentage of U.S. adults turning to primary ca...

## Key facts

- **NIH application ID:** 10375031
- **Project number:** 1R44MH126836-01A1
- **Recipient organization:** MERU HEALTH MEDICAL, P.A.
- **Principal Investigator:** Nicholas Peiper
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $749,689
- **Award type:** 1
- **Project period:** 2022-04-07 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10375031

## Citation

> US National Institutes of Health, RePORTER application 10375031, HYBRID TYPE 1 EFFECTIVENESS-IMPLEMENTATION TRIAL FOR PRIMARY CARE DEPRESSION SCREENING AND REFERRAL TO A REMOTE DIGITAL MENTAL HEALTH CLINIC (1R44MH126836-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10375031. Licensed CC0.

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