Table 2.
Results of intention-to-treat (ITT) outcome measures.
| Measure | Before the intervention, mean (SD) | After the intervention, mean (SD) | Within-group effect sizes, Hedges g (95% CI) | P value |
F (Group× time)a |
P value (Group× time)a |
Between-group effect sizes, Hedges g (95% CI) | ||
| Primary outcome: QOLIE-31b total score | |||||||||
|
|
Intervention (N=107) | 65.22 (7.21) | 75.02 (6.94) | 1.38 (1.07-1.68) | <.001 | 13.10 | <.001 | 0.49 (0.22-0.76) | |
|
|
Control (N=107) | 65.23 (8.09) | 69.79 (7.16) | 0.57 (0.29-0.86) | <.001 | N/Ac | N/A | >N/A | |
| Secondary outcome | |||||||||
|
|
Seizure worry | ||||||||
|
|
|
Intervention (N=107) | 58.33 (13.72) | 77.27 (18.49) | 1.17 (0.87-1.47) | <.001 | 10.18 | <.001 | 0.43, (0.16-0.70) |
|
|
|
Control (N=107) | 59.01 (13.82) | 68.86 (13.72) | 0.74 (0.46-1.03) | <.001 | N/A | N/A | N/A |
|
|
Overall quality of life | ||||||||
|
|
|
Intervention (N=107) | 72.21 (11.35) | 83.80 (16.02) | 0.35 (0.07-0.63) | <.001 | 10.20 | .01 | 0.43 (0.16-0.70) |
|
|
|
Control (N=107) | 75.33 (30.29) | 81.99 (30.72) | 0.12 (0.01 to 0.42) | <.001 | N/A | N/A | N/A |
|
|
Emotional well-being | ||||||||
|
|
|
Intervention (N=107) | 65.42 (8.69) | 80.06 (10.10) | 1.54 (1.22-1.85) | <.001 | 26.51 | <.001 | 0.70 (0.43 to 0.98) |
|
|
|
Control (N=107) | 64.21 (9.85) | 68.63 (10.63) | 0.45 (0.17-0.73) | <.001 | N/A | N/A | N/A |
|
|
Energy or fatigue | ||||||||
|
|
|
Intervention (N=107) | 60.13 (10.37) | 74.14 (10.98) | 1.28 (0.98-1.59) | <.001 | 18.74 | <.001 | 0.58 (0.32-0.86) |
|
|
|
Control (N=107) | 60.40 (10.51) | 65.15 (10.56) | 0.47 (0.19-0.75) | <.001 | N/A | N/A | N/A |
|
|
Cognition | ||||||||
|
|
|
Intervention (N=107) | 64.94 (11.96) | 69.19 (11.74) | 0.37 (0.09-0.65) | <.001 | .083 | 0.57 | 0.04, (–0.23 to 0.31) |
|
|
|
Control (N=107) | 64.29 (12.21) | 67.97 (11.31) | 0.30 (0.03-0.58) | <.001 | N/A | N/A | N/A |
|
|
Medication side effects | ||||||||
|
|
|
Intervention (N=107) | 53.67 (14.63) | 79.57 (14.50) | 1.74 (1.42-2.07) | <.001 | 33.89 | <.001 | 0.79 (0.52-1.07) |
|
|
|
Control (N=107) | 50.07 (13.90) | 58.68 (15.85) | 0.56 (0.28 to 0.84) | <.001 | N/A | N/A | N/A |
|
|
Social function | ||||||||
|
|
|
Intervention (N=107) | 66.18 (9.02) | 72.07 (10.48) | 0.59 (0.30 to 0.87) | <.001 | 1.91 | .09 | 0.19 (–0.08 to 0.46) |
|
|
|
Control (N=107) | 65.49 (10.91) | 69.40 (10.44) | 0.34 (0.06-0.62) | <.001 | N/A | N/A | N/A |
|
|
GAD-7d | ||||||||
|
|
|
Intervention (N=107) | 7.43 (5.95) | 6.76 (5.06) | –0.22 (–0.14 to –0.09) | .008 | .493 | .12 | 010 (–0.17 to 0.36) |
|
|
|
Control (N=107) | 7.17 (5.28) | 5.70 (4.55) | –0.29 (–0.57 to –0.01) | <.001 | N/A | N/A | N/A |
|
|
NDDI-Ee | ||||||||
|
|
|
Intervention (N=107) | 13.04 (5.63) | 10.21 (4.286) | –0.57 (–0.85 to –0.29) | <.001 | 9.28 | .01 | 0.42 (0.15-0.68) |
|
|
|
Control (N=107) | 12.18 (5.10) | 10.63 (4.4.40) | –0.32 (–0.60 to –0.04) | <.001 | N/A | N/A | N/A |
aResults of ITT outcome analysis using linear mixed models.
bQOLIE-31: Quality of Life in Epilepsy-31.
cN/A: not applicable.
dGAD-7: Generalized Anxiety Disorder-7 Scale.
eNDDI-E: Neurological Disorders Depression Inventory for Epilepsy.