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

Abstract

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.