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

Abstract

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 randomized controlled trial. Methods We completed a pragmatic single-blind trial of juli for depression. We included participants aged over 18 who self-identified as having depression and scored 5 or more on the Patient Health Questionnaire-8 (PHQ-8). Participants were randomly assigned (1:1) to receive juli for 8 weeks or a limited attention-placebo control version of the app. Our primary outcome was the difference in PHQ-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 intention-to-treat (secondary). The trial was registered at the ISRCTN registry ( 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). The mean baseline PHQ-8 score was consistent with a diagnosis of moderately severe depression. In the per-protocol analysis, the juli group had a lower mean PHQ-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). Remission and minimal clinically important difference were increased in the juli group at 8 weeks (adjusted odds ratio 2.22, 95%CI 1.45-3.39, p<0.001 and adjusted odds ratio 1.56, 95%CI 1.08 to 2.27, p=0.018). There were no between-group differences in health-related quality of life physical or mental component scores or worsening of depression. Conclusion Use of juli reduced symptoms of depression at 8 weeks compared with an attention-placebo control. The juli app is a digital self-management tool that could increase accessibility of evidence-based depression treatments.

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