Digitally managing depression: A fully remote randomised attention-placebo controlled trial.

Background: Depression is a common and disabling condition. Digital apps may augment or facilitate care, particularly in under-served populations. We tested the efficacy of juli, a digital self-management app for depression in a fully remote randomised controlled trial.
Methods: A pragmatic randomised controlled trial that included participants aged > 18 who self-identified as having depression and scored > 5 on the Patient Health Questionnaire-8. Participants were randomly assigned (1:1) to receive juli for 8 weeks or a limited attention-placebo control app. Our primary outcome was the difference in Patient Health Questionnaire-8 scores at 8 weeks. Secondary outcomes were remission, minimal clinically important difference, worsening of depression, and health-related quality of life. Analyses were per-protocol (primary), and modified and full intention-to-treat (secondary). The trial was registered at ISRCTN (ISRCTN12329547).
Results: Between May 2021 and January 2023, we randomised 908 participants. 662 completed the week 2 outcome assessment and were included in the modified intention-to-treat analysis, and 456 completed the week 8 outcome assessments (per-protocol). In the per-protocol analysis, the juli group had a greater reduction in Patient Health Questionnaire-8 score (10.78, standard deviation 6.26) than the control group (11.88, standard deviation 5.73) by week 8 (baseline adjusted β-coefficient -0.94, 95% CI: -1.87 to -0.22, p  = 0.045). Achieving remission and a minimal clinically important difference was more likely in the juli group at 8 weeks (adjusted odds ratios 2.22, 95% CI: 1.45-3.39, p  < 0.001 and 1.56, 95% CI: 1.08-2.27, p  = 0.018, respectively). There were no between-group differences in health-related quality of life or worsening of depression. Modified and full intention-to-treat analyses found similar results, but the primary outcome was non-significant.
Conclusion: The use of juli for 8 weeks resulted in a small reduction in symptoms of depression compared with an attention-placebo control. The juli app is a digital self-management tool that could increase the accessibility of evidence-based depression treatments.
Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AK, BD, BH, JS, and JH are shareholders in juli Health. AK has received consultancy fees from juli Health and Wellcome Trust. BD, BH, JS, and JH are cofounders of juli Health. JH has received consultancy fees from juli Health and Wellcome Trust. KE has no conflicts of interest. The funders played no part in the analysis of the data.
(© The Author(s) 2024.)