PMID- 38211747 OWN - NLM STAT- MEDLINE DCOM- 20240209 LR - 20240209 IS - 1573-2517 (Electronic) IS - 0165-0327 (Linking) VI - 349 DP - 2024 Mar 15 TI - Therapist-supported digital mental health intervention for depressive symptoms: A randomized clinical trial. PG - 494-501 LID - S0165-0327(24)00068-5 [pii] LID - 10.1016/j.jad.2024.01.057 [doi] AB - 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 Accordingly, this randomized clinical trial (ClinicalTrials.gov: NCT04738084) investigated the efficacy of a newer version of the therapist-supported and guided DMHI, the Meru Health Program (MHP), which was recently enhanced with heart rate variability biofeedback and lengthened from 8-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 %, chi(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. CI - Published by Elsevier B.V. FAU - Forman-Hoffman, Valerie L AU - Forman-Hoffman VL AD - Meru Health, San Mateo, CA, USA; Department of Epidemiology, University of Iowa, Iowa City, IA, USA. FAU - Sihvonen, Samuel AU - Sihvonen S AD - Meru Health, San Mateo, CA, USA. FAU - Wielgosz, Joseph AU - Wielgosz J AD - National Center for PTSD Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, CA, USA. FAU - Kuhn, Eric AU - Kuhn E AD - National Center for PTSD Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. FAU - Nelson, Benjamin W AU - Nelson BW AD - Meru Health, San Mateo, CA, USA; Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Peiper, Nicholas C AU - Peiper NC AD - Meru Health, San Mateo, CA, USA; Department of Epidemiology and Population Health, University of Louisville, Louisville, KY, USA. FAU - Gould, Christine E AU - Gould CE AD - Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA; Geriatric Research Education and Clinical Center, VA Palo Alto Health Care System, Palo Alto, CA, USA. Electronic address: cegould@stanford.edu. LA - eng SI - ClinicalTrials.gov/NCT04738084 GR - R44 MH126836/MH/NIMH NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial DEP - 20240109 PL - Netherlands TA - J Affect Disord JT - Journal of affective disorders JID - 7906073 SB - IM MH - Humans MH - Adult MH - *Depression/therapy/psychology MH - Mental Health MH - Quality of Life MH - *Cognitive Behavioral Therapy/methods MH - Anxiety/psychology OTO - NOTNLM OT - Depression OT - Health technology mental health services OT - Smartphone COIS- 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. EDAT- 2024/01/12 00:42 MHDA- 2024/02/09 06:43 CRDT- 2024/01/11 19:14 PHST- 2023/07/11 00:00 [received] PHST- 2023/12/15 00:00 [revised] PHST- 2024/01/04 00:00 [accepted] PHST- 2024/02/09 06:43 [medline] PHST- 2024/01/12 00:42 [pubmed] PHST- 2024/01/11 19:14 [entrez] AID - S0165-0327(24)00068-5 [pii] AID - 10.1016/j.jad.2024.01.057 [doi] PST - ppublish SO - J Affect Disord. 2024 Mar 15;349:494-501. doi: 10.1016/j.jad.2024.01.057. Epub 2024 Jan 9.