Mood and Activity Measured Using Smartphones in Unipolar Depressive Disorder.

Background: Smartphones comprise a promising tool for symptom monitoring in patients with unipolar depressive disorder (UD) collected as either patient-reportings or possibly as automatically generated smartphone data. However, only limited research has been conducted in clinical populations. We investigated the association between smartphone-collected monitoring data and validated psychiatric ratings and questionnaires in a well-characterized clinical sample of patients diagnosed with UD. Methods: Smartphone data, clinical ratings, and questionnaires from patients with UD were collected 6 months following discharge from psychiatric hospitalization as part of a randomized controlled study. Smartphone data were collected daily, and clinical ratings (i.e., Hamilton Depression Rating Scale 17-item) were conducted three times during the study. We investigated associations between (1) smartphone-based patient-reported mood and activity and clinical ratings and questionnaires; (2) automatically generated smartphone data resembling physical activity, social activity, and phone usage and clinical ratings; and (3) automatically generated smartphone data and same-day smartphone-based patient-reported mood and activity. Results: A total of 74 patients provided 11,368 days of smartphone data, 196 ratings, and 147 questionnaires. We found that: (1) patient-reported mood and activity were associated with clinical ratings and questionnaires (p < 0.001), so that higher symptom scores were associated with lower patient-reported mood and activity, (2) Out of 30 investigated associations on automatically generated data and clinical ratings of depression, only four showed statistical significance. Further, lower psychosocial functioning was associated with fewer daily steps (p = 0.036) and increased number of incoming (p = 0.032), outgoing (p = 0.015) and missed calls (p = 0.007), and longer phone calls (p = 0.012); (3) Out of 20 investigated associations between automatically generated data and daily patient-reported mood and activity, 12 showed statistical significance. For example, lower patient-reported activity was associated with fewer daily steps, shorter distance traveled, increased incoming and missed calls, and increased screen-time. Conclusion: Smartphone-based self-monitoring is feasible and associated with clinical ratings in UD. Some automatically generated data on behavior may reflect clinical features and psychosocial functioning, but these should be more clearly identified in future studies, potentially combining patient-reported and smartphone-generated data.

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.

Methodological Challenges in Randomized Controlled Trials on Smartphone-Based Treatment in Psychiatry: Systematic Review.

BACKGROUND: Smartphone-based technology is developing at high speed, and many apps offer potential new ways of monitoring and treating a range of psychiatric disorders and symptoms. However, the effects of most available apps have not been scientifically investigated. Within medicine, randomized controlled trials (RCTs) are the standard method for providing the evidence of effects. However, their rigidity and long time frame may contrast with the field of information technology research. Therefore, a systematic review of methodological challenges in designing and conducting RCTs within mobile health is needed. OBJECTIVE: This systematic review aimed to (1) identify and describe RCTs investigating the effect of smartphone-based treatment in adult patients with a psychiatric diagnosis, (2) discuss methodological challenges in designing and conducting individual trials, and (3) suggest recommendations for future trials. METHODS: A systematic search in English was conducted in PubMed, PsycINFO, and EMBASE up to August 12, 2019. The search terms were (1) psychiatric disorders in broad term and for specific disorders AND (2) smartphone or app AND (3) RCT. The Consolidated Standards of Reporting Trials electronic health guidelines were used as a template for data extraction. The focus was on trial design, method, and reporting. Only trials having sufficient information on diagnosis and acceptable diagnostic procedures, having a smartphone as a central part of treatment, and using an RCT design were included. RESULTS: A total of 27 trials comprising 3312 patients within a range of psychiatric diagnoses were included. Among them, 2 trials were concerning drug or alcohol abuse, 3 psychosis, 10 affective disorders, 9 anxiety and posttraumatic stress disorder, 1 eating disorder, and 1 attention-deficit/hyperactivity disorder. In addition, 1 trial used a cross-diagnostic design, 7 trials included patients with a clinical diagnosis that was subsequently assessed and validated by the researchers, and 11 trials had a sample size above 100. Generally, large between-trial heterogeneity and multiple approaches to patient recruitment, diagnostic procedures, trial design, comparator, outcome measures, and analyses were identified. Only 5 trials published a trial protocol. Furthermore, 1 trial provided information regarding technological updates, and only 18 trials reported on the conflicts of interest. No trial addressed the ethical aspects of using smartphones in treatment. CONCLUSIONS: This first systematic review of the methodological challenges in designing and conducting RCTs investigating smartphone-based treatment in psychiatric patients suggests an increasing number of trials but with a lower quality compared with classic medical RCTs. Heterogeneity and methodological issues in individual trials limit the evidence. Methodological recommendations are presented.