Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Jul 1;7(7):e2422115.
doi: 10.1001/jamanetworkopen.2024.22115.

Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services: A Randomized Clinical Trial

Adam G Horwitz  1 , Elizabeth D Mills  2 , Srijan Sen  1   3 , Amy S B Bohnert  1   2
Affiliations
Randomized Controlled Trial

Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services: A Randomized Clinical Trial

Adam G Horwitz et al. JAMA Netw Open. .

Abstract

Importance: There is a substantial gap between demand for and availability of mental health services. Digital mental health interventions (DMHIs) are promising tools for bridging this gap, yet little is known about their comparative effectiveness.

Objective: To assess whether patients randomized to a cognitive behavioral therapy (CBT)-based or mindfulness-based DMHI had greater improvements in mental health symptoms than patients randomized to the enhanced personalized feedback (EPF)-only DMHI.

Design,: SETTING, AND PARTICIPANTS This randomized clinical trial was conducted between May 13, 2020, and December 12, 2022, with follow-up at 6 weeks. Adult patients of outpatient psychiatry services across various clinics within the University of Michigan Health System with a scheduled or recent outpatient psychiatry appointment were recruited. Eligible patients were randomized to an intervention arm. All analyses followed the intent-to-treat principle.

Interventions: Participants were randomized to 1 of 5 intervention arms: (1) EPF only; (2) Silvercloud only, a mobile application designed to deliver CBT strategies; (3) Silvercloud plus EPF; (4) Headspace only, a mobile application designed to train users in mindfulness practices; and (5) Headspace plus EPF.

Main outcomes and measures: The primary outcome was change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9; score range: 0-27, with higher scores indicating greater depression symptoms). Secondary outcomes included changes in anxiety, suicidality, and substance use symptoms.

Results: A total of 2079 participants (mean [SD] age, 36.8 [14.3] years; 1423 self-identified as women [68.4%]) completed the baseline survey. The baseline mean (SD) PHQ-9 score was 12.7 (6.4) and significantly decreased for all 5 intervention arms at 6 weeks (from -2.1 [95% CI, -2.6 to -1.7] to -2.9 [95% CI, -3.4 to -2.4]; n = 1885). The magnitude of change was not significantly different across the 5 arms (F4,1879 = 1.19; P = .31). Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported significantly greater improvements on a suicidality measure subscale compared with the Silvercloud arms (mean difference in mean change = 0.63; 95% CI, 0.20-1.06; P = .004).

Conclusions and relevance: This randomized clinical trial found decreases in depression and anxiety symptoms across all DMHIs and minimal evidence that specific applications were better than others. The findings suggest that DMHIs may provide support for patients during waiting list-related delays in care.

Trial registration: ClinicalTrials.gov Identifier: NCT04342494.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Drs Sen, Bohnert, and Mills reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. Flow Diagram of Study Participants
EPF indicates enhanced personalized feedback.
See this image and copyright information in PMC

References

    1. Christensen MK, Lim CCW, Saha S, et al. . The cost of mental disorders: a systematic review. Epidemiol Psychiatr Sci. 2020;29:e161. doi:10.1017/S204579602000075X - DOI - PMC - PubMed
    1. Center for Behavioral Health Statistics and Quality . 2021 National Survey on Drug Use and Health: detailed tables. 2023. Accessed October 2023. https://www.samhsa.gov/data/report/2021-nsduh-detailed-tables
    1. Greenberg PE, Fournier AA, Sisitsky T, et al. . The economic burden of adults with major depressive disorder in the United States (2010 and 2018). Pharmacoeconomics. 2021;39(6):653-665. doi:10.1007/s40273-021-01019-4 - DOI - PMC - PubMed
    1. Sun CF, Correll CU, Trestman RL, et al. . Low availability, long wait times, and high geographic disparity of psychiatric outpatient care in the US. Gen Hosp Psychiatry. 2023;84:12-17. doi:10.1016/j.genhosppsych.2023.05.012 - DOI - PubMed
    1. Vahratian A, Blumberg SJ, Terlizzi EP, Schiller JS. Symptoms of anxiety or depressive disorder and use of mental health care among adults during the COVID-19 pandemic - United States, August 2020-February 2021. MMWR Morb Mortal Wkly Rep. 2021;70(13):490-494. doi:10.15585/mmwr.mm7013e2 - DOI - PMC - PubMed

Publication types

Associated data