Table 4.
Descriptive statistics and main comparisons for primary and secondary outcomes at 3-month follow-up.
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Participants, n (intervention, iTAUa) | Intervention + iTAU, mean (SD) | iTAU alone, mean (SD) | Within group, B (95% CI) | Between group | |||||||||||||
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Intervention + iTAU | iTAU alone | d | P valueb | B (95% CI) | ||||||||||
| Primary outcome | ||||||||||||||||||
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Composite (range –2.25 to 2.25) | 46, 50 |
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Baseline |
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–0.10 (0.79) | –0.01 (0.80) | —c | — | — | — | — | ||||||||
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Follow-up |
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–0.21 (0.86) | 0.19 (0.86) | –0.13 (–0.37 to – 0.02) | 0.20 (–0.02 to 0.43) | –0.39 | .02 | –0.34 (–0.64 to –0.04) | ||||||||
| Secondary outcomes | ||||||||||||||||||
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PHQ-9d (range 0-27) | 47, 61 |
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Baseline |
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13.89 (5.97) | 13.41 (5.45) | — | — | — | — | — | ||||||||
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Follow-up |
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9.79 (6.46) | 13.05 (6.45) | –4.30 (–5.56 to –3.04) | –0.50 (–1.73 to 0.72) | –0.65 | <.001 | –3.92 (–5.70 to –2.15) | ||||||||
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RMDQe (range 0-24) | 33, 44 |
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Baseline |
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13.36 (5.49) | 14.00 (6.05) | — | — | — | — | — | ||||||||
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Follow-up |
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13.06 (6.28) | 14.39 (6.18) | –0.36 (–1.90 to 1.18) | 0.04 (–0.87 to 0.95) | –0.12 | .43 | –0.74 (–2.58 to1.10) | ||||||||
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FPS-Rf (range 0-10) | 33, 44 |
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Baseline |
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4.67 (1.78) | 5.00 (2.18) | — | — | — | — | — | ||||||||
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Follow-up |
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5.21 (2.50) | 5.73 (2.05) | 0.43 (–0.37 to 1.23) | 0.65 (–0.13 to 1.43) | –0.10 | .79 | –0.14 (–1.13 to 0.86) | ||||||||
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HbA1cg (diabetes: ≥6.5) | 16, 5 |
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Baseline |
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6.73 (0.66) | 7.54 (1.40) | — | — | — | — | — | ||||||||
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Follow-up |
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6.89 (1.31) | 7.54 (2.08) | 0.23 (–0.26 to 0.72) | –0.01 (–0.78 to 0.77) | 0.18 | .60 | 0.23 (–0.61 to 1.07) | ||||||||
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SF-12h (range 0-100) | 47, 60 |
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Baseline |
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33.91 (19.43) | 33.17 (17.81) | — | — | — | — | — | ||||||||
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Follow-up |
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43.46 (24.01) | 33.04 (21.95) | 10.81 (5.98 to15.64) | 1.19 (–2.25 to 4.63) | 0.52 | .002 | 9.04 (3.21 to 14.87) | ||||||||
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PANASi-positive subscale (range 10-50) | 44, 59 |
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Baseline |
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20.68 (7.14) | 21.47 (7.05) | — | — | — | — | — | ||||||||
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Follow-up |
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25.36 (9.77) | 21.24 (8.88) | 4.84 (2.04 to 7.64) | –0.03 (–1.86 to 1.80) | 1.13 | .001 | 4.73 (2.01 to 7.45) | ||||||||
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PANAS-negative subscale (range 10-50) | 44, 59 |
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Baseline |
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25.89 (8.50) | 27.17 (8.46) | — | — | — | — | — | ||||||||
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Follow-up |
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21.09 (8.34) | 25.47 (9.31) | –5.05 (–7.14 to – 2.95) | –1.32 (–3.14 to 0.50) | –0.36 | .02 | –3.67 (–6.63 to –0.71) | ||||||||
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OFSj (range 10-50) | 47, 60 |
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Baseline |
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31.02 (7.86) | 30.43 (8.18) | — | — | — | — | — | ||||||||
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Follow-up |
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34.06 (9.01) | 30.32 (8.13) | 3.13 (0.98 to 5.29) | 0.03 (–1.60 to 1.68) | 0.39 | .02 | 3.08 (0.55 to 5.62) | ||||||||
aiTAU: improved treatment as usual.
bAll significant results remained significant after correction for multiple comparisons using the Benjamini-Hochberg method.
cNot applicable.
dPHQ-9: Patient Health Questionnaire-9.
eRMDQ: Rolland-Morris Disability Questionnaire.
fFPS-R: Faces Pain Scale-Revised.
gHbA1c: glycosylated hemoglobin.
hSF-12: 12-item Short Form Survey.
iPANAS: Positive and Negative Affect Scale.
jOFS: Openness to the Future Scale.