| Literature DB >> 36120713 |
Ellen Frank1,2, Meredith L Wallace1, Mark L Matthews2,3, Jeremy Kendrick4, Jeremy Leach2, Tara Moore2, Gabriel Aranovich2, Tanzeem Choudhury2,5, Nirav R Shah6, Zeenia Framroze7, Greg Posey2, Samuel Burgess2, David J Kupfer1,2.
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 software solution based on social rhythm regulation principles. The full intent-to-treat (ITT) sample consisted of 133 individuals, aged 18-65. An exploratory sub-sample of interest was those individuals who presented with moderately severe to severe depression at study entry (baseline PHQ-8 score ≥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 precision digital intervention of which we are aware. Participants were randomly allocated to receive Cue plus care-as-usual or digital monitoring only plus care as usual. Within the full study and depressed-at-entry 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 non-linear 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 full sample, the group difference in the slope of PHQ-8 was negligible (Cohen's d = -0.10); however, the Cue group demonstrated significantly greater improvement from baseline to 16 weeks (p = 0.040). In the depressed-at-entry sample, we found evidence for benefit of Cue. The 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). 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).Entities:
Keywords: depression; depressive symtpoms; digital intervention platform; passive monitoring; social rhythm disruption; social rhythm regularity; treatment
Year: 2022 PMID: 36120713 PMCID: PMC9478192 DOI: 10.3389/fdgth.2022.870522
Source DB: PubMed Journal: Front Digit Health ISSN: 2673-253X
Figure 1Design of RCT comparing a digital intervention platform with monitoring only.
Figure 2Sample learning module screens.
Figure 3Sample micro-intervention/behavior change suggestion.
Figure 4CONSORT diagram.
Demographic and clinical characteristics for the full study sample – Cells show mean (SD) for continuous and % (N) for categorical measures.
| All ( | Cue ( | Measure ( | Comparison | |
|---|---|---|---|---|
|
| ||||
| Age | 32.94 (11.39) | 33.85 (11.64) | 32.04 (11.15) | |
| Female | 73.68 (98) | 72.73 (48) | 74.63 (50) | |
| Employment Status | ||||
| Full Time Work | 60.15 (80) | 65.15 (43) | 55.22 (37) | |
| Part Time Work | 25.56 (34) | 19.7 (13) | 31.34 (21) | |
| Not Working | 14.29 (19) | 15.15 (10) | 13.43 (9) | |
| Living Situation | ||||
| Living Alone | 17.29 (23) | 22.73 (15) | 11.94 (8) | |
| Living with Family | 63.91 (85) | 65.15 (43) | 62.69 (42) | |
| Living with Unrelated People | 18.8 (25) | 12.12 (8) | 25.37 (17) | |
|
| ||||
| First PHQ | 11.02 (4.74) | 11.53 (5.14) | 10.52 (4.28) | |
| First PHQ ≥15 | 21.05 (28) | 24.24 (16) | 17.91 (12) | |
| Depression or anxiety medication | 80.45 (107) | 80.3 (53) | 80.6 (54) | |
| Lifetime diagnosis | ||||
| Mood disorder only | 18.8 (25) | 18.18 (12) | 19.4 (13) | |
| Anxiety disorder only | 11.28 (15) | 7.58 (5) | 14.93 (10) | |
| Mood and anxiety disorder | 69.92 (93) | 74.24 (49) | 65.67 (44) | |
Demographic and clinical characteristics for the depressed-at-entry exploratory subsample (baseline PHQ ≥ 15) – Cells show mean (SD) for continuous and % (N) for categorical measures.
| All ( | Cue ( | Measure ( | Comparison | |
|---|---|---|---|---|
|
| ||||
| Age | 34.04 (10.37) | 34.31 (10.28) | 33.67 (10.93) | |
| Female | 78.57 (22) | 68.75 (11) | 91.67 (11) | |
| Employment Status | ||||
| Full Time Work | 75 (21) | 75 (12) | 75 (9) | |
| Part Time Work | 10.71 (3) | 6.25 (1) | 16.67 (2) | |
| Not Working | 14.29 (4) | 18.75 (3) | 8.33 (1) | |
| Living Situation | ||||
| Living Alone | 17.86 (5) | 25 (4) | 8.33 (1) | |
| Living with Family | 71.43 (20) | 68.75 (11) | 75 (9) | |
| Living with Unrelated People | 10.71 (3) | 6.25 (1) | 16.67 (2) | |
|
| ||||
| First PHQ | 17.57 (2.33) | 18.56 (2.42) | 16.25 (1.42) | |
| Depression or Anxiety Medication | 89.29 (25) | 87.5 (14) | 91.67 (11) | |
| Lifetime diagnosis | ||||
| Mood disorder only | 17.86 (5) | 12.5 (2) | 25 (3) | |
| Anxiety disorder only | 10.71 (3) | 6.25 (1) | 16.67 (2) | |
| Mood and Anxiety disorder | 71.43 (20) | 81.25 (13) | 58.33 (7) | |
Figure 5Loess trajectories of PHQ-8 for Cue and measure (control) conditions in full study sample.
Figure 6Means and standard errors of PHQ scores by study week-full sample.
Figure 7Loess trajectories of PHQ-8 for Cue and measure (control) conditions in depressed-at entry participants (initial PHQ-8 ≥ 15).
Figure 8Means and standard errors of PHQ scores by study week-full sample.