No abstract

We conducted a 16-week randomized controlled trial in psychiatric outpatients with a lifetime diagnosis of a mood and/or anxiety disorder to measure the impact of a first of its kind precision digital intervention based on social rhythm regulation principles (Cue). The full intent to treat (ITT) sample consisted of 133 individuals, aged 18 to 65. The primary sample of interest were individuals with moderately severe to severe depression at study entry (baseline PHQ-8 score greater than or equal to 15; N=28).Cue is a novel digital intervention platform that capitalizes on the smartphone’s ability to continuously monitor depression relevant behavior patterns and use each patient’s behavioral data to provide timely, personalized micro interventions, making this the first example of a digital precision intervention that we are aware of. Participants were randomly allocated to receive Cue plus care as usual or digital monitoring only plus care as usual.Within the depressed and full ITT samples, we fit a mixed effects model to test for group differences in the slope of depressive symptoms over 16 weeks. To account for the nonlinear trajectory with more flexibility, we also fit a mixed effects model considering week as a categorical variable and used the resulting estimates to test the group difference in PHQ change from baseline to 16 weeks.In the depressed at entry sample, we found evidence for benefit of Cue. The large group difference in the slope of PHQ-8 (Cohen’s d= -0.72) indicated a meaningfully more rapid rate of improvement in the intervention group than in the control group. The Cue group also demonstrated significantly greater improvement in PHQ-8 from baseline to 16 weeks (p=0.009). In the full sample, the group difference in the slope of PHQ-8 was negligible (Cohen’s d=-0.10); however, the Cue group again demonstrated significantly greater improvement from baseline to 16 weeks (p=0.040).We are encouraged by the size of the intervention effect in those who were acutely ill at baseline and by the finding that across all participants, 80% of whom were receiving pharmacotherapy, we observed significant benefit of Cue at 16 weeks of treatment. These findings suggest that a social rhythm focused digital intervention platform may represent a useful and accessible adjunct to antidepressant treatment.(https://clinicaltrials.gov/ct2/show/NCT03152864?term=ellen+frank&draw=2&rank=3)