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Design and Participants: This trial (conducted 2020-2022, with follow-up at 6 weeks) assessed whether a CBT-based or mindfulness-based DMHI yielded greater improvements in mental health symptoms vs EPF-only DMHI. Adults receiving outpatient psychiatry services across various clinics within the University of Michigan Health System with a scheduled or recent outpatient psychiatry appointment were randomized: (1) EPF only; (2) SilverCloud only, a mobile application designed to deliver CBT strategies; (3) SilverCloud+EPF; (4) Headspace only, a mobile application designed to train users in mindfulness practices; or (5) Headspace+EPF. The primary outcome was change in depressive symptoms measured via Patient Health Questionnaire-9 (PHQ-9; range=0-27, higher indicating greater depression). Secondary outcomes included changes in anxiety, suicidality, and substance use symptoms. Analyses (intent to treat) used analysis of covariance and logistic regression.
Results: Participants (N=2,079) were aged mean 37 years (SD=14), and 68% self-identified as women. The mean baseline PHQ-9 score was 13 (SD=6.4) and decreased for all arms at 6 weeks (−2.1 [95% CI=−2.6 to −1.7] to −2.9 [−3.4 to −2.4]). The magnitude of change on the PHQ-9 was not different across arms (F4,1879=1.2; P=.31). Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported greater improvements on a suicidality measure subscale vs the SilverCloud arms (mean difference in mean change=0.63; 95% CI=0.20-1.1).
Commentary: The diagnosis of any serious health condition can cause increased psychological distress. Despite the Mental Health Parity and Addiction Equity Act enacted in 2008, which attempted to reduce barriers to mental health access or substance use disorder benefits, a wide gap remains between the demand and capacity for these services. This large, pragmatic randomized clinical trial reported modest improvements in depression and anxiety symptoms across all DMHIs, with the Headspace intervention associated with a significant but small improvement in protective factors, potentially reducing suicidality. DMHIs may improve access and may be offered as supplemental tools for mental health support, but the modest improvements in symptoms suggest they are unlikely to replace one-on-one interactions with healthcare providers. Access via smartphones and out-of-pocket costs are potential limitations to accessing DMHIs.
Bottom Line: All DMHIs demonstrated modest reduction in anxiety and depression symptoms and may improve access to mental healthcare for patients during waitlist-related delays.
Reviewer: Rony Dev, DO, The University of Texas MD Anderson Cancer Center, Houston, TX
References:
1. Goldberg SB, Lam SU, Simonsson O, Torous J, Sun S. Mobile phone-based interventions for mental health: a systematic meta-review of 14 meta-analyses of randomized controlled trials. PLOS Digit Health. 2022;1(1): e0000002. doi:10.1371/journal.pdig.0000002.
2. Hirschtritt ME, Insel TR. Digital technologies in psychiatry: present and future. Focus (Am Psychiatr Publ). 2018;16(3):251-258. doi:10.1176/appi.focus.20180001.
Source: Horwitz AG, Mills ED, Sen S, Bohnert ASB. Comparative effectiveness of three digital interventions for adults seeking psychiatric services: a randomized clinical trial. JAMA Netw Open. 2024;7(7):e2422115. doi:10.1001/jamanetworkopen.2024.22115.
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