Table 1.
DTxa clinical trial demographic data from the Digital Therapeutics Alliance Product Library: reSet-0, Reset, FreeSpira, and Deprexis.
| Digital Therapeutic Product | reSet-0 | Reset | FreeSpira | Deprexis | ||||||
| Company | Pear Therapeutics | Pear Therapeutics | FreeSpira Inc | Orexo | ||||||
| FDAb regulation | FDA cleared | FDA-cleared class II medical device | FDA cleared | —c | ||||||
| Study type | Randomized controlled trial | Randomized controlled trial | Randomized controlled trial | Randomized controlled trial | ||||||
| Name of study | Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence | Internet-delivered treatment for substance abuse: a multisite randomized controlled trial | Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder | Effectiveness of an internet intervention (Deprexis) for depression in a United States adult sample: a parallel-group pragmatic randomized controlled trial | ||||||
| Digital therapeutic clinical area of focus | Opioid use disorder | Substance use disorder | Panic disorder/PTSDd | Depression | ||||||
| Prescription required? | Yes | Yes | Yes | No | ||||||
| Demographics | ||||||||||
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Sample size, n | 170 | 507 | 37 | 376 | |||||
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Age (years) | Mean 34.3 (SD 9.9) | Mean 34.9 (SD 10.9) | Range 18-60 | Mean 31.9 (SD 11.2) | |||||
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Sex, n (%) | |||||||||
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Male | 92 (54.1) | 315 (62.1) | 13 (35.0) | 93 (24.7) | ||||
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Female | 78 (45.9) | 192 (37.9) | 24 (65.0) | 280 (74.4) | ||||
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Race, n (%) | |||||||||
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Asian | 0 (0) | 13 (2.6) | 3 (8.1) | 27 (7.2) | ||||
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Black | 0 (0) | 116 (22.9) | 1 (2.7) | 15 (3.9) | ||||
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White | 162 (95.3) | 284 (56.0) | 32 (86.5) | 291 (77.3) | ||||
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Others | 8 (4.7) | 92 (18.1) | 0 (0) | 3 (0.8) | ||||
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Ethnicity, n (%) | |||||||||
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Hispanic | N/A | 55 (10.8) | 1 (2.7) | 42 (11.1) | ||||
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Non-Hispanic | — | 452 (89.2) | 36 (97.3) | 325 (86.4) | ||||
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Education: some college or more | Median 12 (IQR 12-14)e | n=79 (15.6%) | — | n=324 (86.2%) | |||||
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Employment: employed at least half time n (%) | 62 (36.6) | 317 (62.5) | — | — | |||||
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Married, remarried, or partnered, n (%) | Never married: 44f | 72 (14.2) | 22 (59.5) | 71 (19.1) | |||||
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Percentage of participants with private insurance (%) | — | 100 | — | — | |||||
aDTx: digital therapeutics.
bFDA: Food and Drug Administration.
cData not available in study.
dPTSD: posttraumatic stress disorder.
eStudy reported education as either mean years with range or median with IQR.
fStudy only reported number and percentage of “never married” individuals for marriage status.