Therapist-supported digital mental health intervention for depressive symptoms: A randomized clinical trial.

Depression is a chronic and debilitating mental disorder. Despite the existence of several evidence-based treatments, many individuals suffering from depression face myriad structural barriers to accessing timely care which may be alleviated by digital mental health interventions (DMHI). Accordingly, this randomized clinical trial (ClinicalTrials.gov: NCT04738084) investigated the efficacy of a newer version of the therapist-supported and guided DMHI, the Meru Health Program (MHP), which was recently enhanced with heart rate variability biofeedback and lengthened from 8- to 12-weeks duration, among people with elevated depression symptoms (N = 100, mean age 37). Recruited participants were randomized to the MHP (n = 54) or a waitlist control (n = 46) condition for 12 weeks. The MHP group had greater decreases in depression symptoms compared to the waitlist control (d = -0.8). A larger proportion of participants in the MHP group reported a minimal clinically important difference (MCID) in depression symptoms than participants in the waitlist control group (39.1 % vs. 9.8 %, χ ² (1) = 9.90, p = .002). Similar effects were demonstrated for anxiety symptoms, quality of life, insomnia, and resilience. The results confirm the utility of the enhanced MHP in reducing depression symptoms and associated health burdens.
Competing Interests: Declaration of competing interest Dr. Peiper reports research support from the National Institute of Mental Health (R44MH126836), Lilly Oncology, Gilead Sciences, and the Norton Healthcare Foundation. Drs. Peiper and Forman-Hoffman report stock options from Meru Health. Drs. Forman-Hoffman and Nelson were employed by Meru Health during the conduct of this research. They are now with Woebot Health and Verily Life Sciences, respectively. Dr. Peiper was employed by Meru Health; he continues to be at the Department of Epidemiology and Population Health, University of Louisville, Louisville, KY. Dr. Gould previously received funding from Meru Health, Inc., for an investigator-initiated study.
(Published by Elsevier B.V.)