Morten Lindbjerg Tønning1, Maria Faurholt-Jepsen2, Mads Frost3, Klaus Martiny2, Nanna Tuxen2, Nicole Rosenberg2, Jonas Busk4, Ole Winther5, Sigurd Arne Melbye2, Daniel Thaysen-Petersen6, Kate Andreasson Aamund7, Lizzie Tolderlund7, Jakob Eyvind Bardram8, Lars Vedel Kessing2. 1. Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Blegdamsvej 9, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: morten.lindbjerg.toenning@regionh.dk. 2. Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Blegdamsvej 9, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. 3. Monsenso A/S, Ny Carlsberg Vej 80, Copenhagen, Denmark. 4. Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark; Copenhagen Center for Health Technology, Denmark. 5. Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark; Bioinformatics Centre, Department of Biology, University of Copenhagen; Centre for Genomic Medicine, Rigshospitalet, Copenhagen University Hospital. 6. Psychiatric Center Ballerup, Denmark. 7. Psychiatric Center North Zealand, Denmark. 8. Monsenso A/S, Ny Carlsberg Vej 80, Copenhagen, Denmark; Copenhagen Center for Health Technology, Denmark; Department of Health Technology, Technical University of Denmark, Lyngby, Denmark.
Abstract
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.
RCT Entities:
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.
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