The effect of smartphone-based monitoring and treatment on the rate and duration of psychiatric readmission in patients with unipolar depressive disorder: The RADMIS randomized controlled trial.

BACKGROUND: Patients with unipolar depressive disorder are frequently hospitalized, and the period following discharge is a high-risk-period. Smartphone-based treatments are receiving increasing attention among researchers, clinicians, and patients. We aimed to investigate whether a smartphone-based monitoring and treatment system reduces the rate and duration of readmissions, more than standard treatment, in patients with unipolar depressive disorder following hospitalization. METHODS: We conducted a pragmatic, investigator-blinded, randomized controlled trial. The intervention group received a smartphone-based monitoring and treatment system in addition to standard treatment. The system allowed patients to self-monitor symptoms and access psycho-educative information and cognitive modules. The patients were allocated a study-nurse who, based on the monitoring data, guided and supported them. The control group received standard treatment. The trial lasted six months, with outcome assessments at 0, 3, and 6 months. RESULTS: We included 120 patients with unipolar depressive disorder (ICD-10). Intention-to-treat analyses showed no statistically significant differences in time to readmission (Log-Rank p=0.9) or duration of readmissions (B=-16.41,95%CI:-47.32;25.5,p=0.3) (Primary outcomes). There were no differences in clinically rated depressive symptoms (p=0.6) or functioning (p=0.1) (secondary outcomes). The intervention group had higher levels of recovery (B=7,29, 95%CI:0.82;13,75,p=0.028) and a tendency towards higher quality of life (p=0.07), wellbeing (p=0,09) satisfaction with treatment (p=0.05) and behavioral activation (p=0.08) compared with the control group (tertiary outcomes). LIMITATIONS: Patients and study-nurses were unblinded to allocation. CONCLUSIONS: We found no effect of the intervention on primary or secondary outcomes. In tertiary outcomes, patients in the intervention group reported higher levels of recovery compared to the control group.

Reducing the rate of psychiatric re-admissions in bipolar disorder using smartphones-The RADMIS trial.

OBJECTIVES: The MONARCA I and II trials were negative but suggested that smartphone-based monitoring may increase quality of life and reduce perceived stress in bipolar disorder (BD). The present trial was the first to investigate the effect of smartphone-based monitoring on the rate and duration of readmissions in BD. METHODS: This was a randomized controlled single-blind parallel-group trial. Patients with BD (ICD-10) discharged from hospitalization in the Mental Health Services, Capital Region of Denmark were randomized 1:1 to daily smartphone-based monitoring including a feedback loop (+ standard treatment) or to standard treatment for 6 months. Primary outcomes: the rate and duration of psychiatric readmissions. RESULTS: We included 98 patients with BD. In ITT analyses, there was no statistically significant difference in rates (hazard rate: 1.05, 95% CI: 0.54; 1.91, p = 0.88) or duration of readmission between the two groups (B: 3.67, 95% CI: -4.77; 12.11, p = 0.39). There was no difference in scores on the Hamilton Depression Rating Scale (B = -0.11, 95% CI: -2.50; 2.29, p = 0.93). The intervention group had higher scores on the Young Mania Rating Scale (B: 1.89, 95% CI: 0.0078; 3.78, p = 0.050). The intervention group reported lower levels of perceived stress (B: -7.18, 95% CI: -13.50; -0.86, p = 0.026) and lower levels of rumination (B: -6.09, 95% CI: -11.19; -1.00, p = 0.019). CONCLUSIONS: Smartphone-based monitoring did not reduce rate and duration of readmissions. There was no difference in levels of depressive symptoms. The intervention group had higher levels of manic symptoms, but lower perceived stress and rumination compared with the control group.