Table 2.
Descriptive summaries of primary and secondary outcome measures
|
Baseline |
6 months |
12 months |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Standardised medical care (n=182) | CBT plus standardised medical care (n=186) | Overall (n=368) | Standardised medical care (n=182) | CBT plus standardised medical care (n=186) | Overall (n=368) | Standardised medical care (n=182) | CBT plus standardised medical care (n=186) | Overall (n=368) | |
| Monthly seizure frequency | |||||||||
| Patients with available data, n (%) | 182 (100%) | 186 (100%) | 368 (100%) | 162 (89%) | 161 (87%) | 323 (88%) | 157 (86%) | 156 (84%) | 313 (85%) |
| Median seizure frequency (IQR; range) | 19 (5–49;0–649) | 12·5 (4–41; 0–535) | 15 (4–47;0–649) | 18 (3–48;0–640) | 6 (0–24;0–849) | 9 (1–38;0–849) | 7 (1–35;0–994) | 4 (0–20;0–571) | 5 (0–27;0–994) |
| Seizure severity* | |||||||||
| Patients with available data, n (%) | 179 (98%) | 182 (98%) | 361 (98%) | 135 (74%) | 125 (67%) | 260 (71%) | 130 (71%) | 129 (69%) | 259 (70%) |
| Mean score (SD; range) | 4·8 (1·6;1–7) | 4·7 (1·6;1–7) | 4·7 (1·6;1–7) | 4·4 (1·6;1–7) | 3·9 (1·9;1–7) | 4·1 (1·8;1–7) | 4·1 (1·8;1–7) | 3·8 (1·8;1–7) | 4·0 (1·8;1–7) |
| Seizure bothersomeness† | |||||||||
| Patients with available data, n (%) | 180 (99%) | 182 (98%) | 362 (98%) | 143 (79%) | 134 (72%) | 277 (75%) | 132 (73%) | 131 (70%) | 263 (71%) |
| Mean score (SD; range) | 5·4 (1·7;1–7) | 5·2 (1·7;1 −7) | 5·3 (1·7;1–7) | 4·7 (2·0;1–7) | 3·9 (2·1;1–7) | 4·3 (2·1;1–7) | 4·6 (2·1;1–7) | 3·9 (2·0;1–7) | 4·2 (2·1;1–7) |
| Longest period of seizure freedom in past 6 months | |||||||||
| Patients with available data, n (%) | 181 (99%) | 186 (100%) | 367 (100%) | NA | NA | NA | 143 (79%) | 140 (75%) | 283 (77%) |
| Median number of seizure-free days* (IQR; range) | 7 (2–21;0–84) | 7 (2–21;0 −119) | 7 (2–21;0–119) | NA | NA | NA | 12 (3–42;0–343) | 21 (5–97·5;0–357) | 14 (3–70;0–357) |
| Seizure freedom in past 3 months | |||||||||
| Patients with available data, n (%) | NA | NA | NA | NA | NA | NA | 145 (80%) | 148 (80%) | 293 (80%) |
| Yes, n (%) | NA | NA | NA | NA | NA | NA | 18 (12%) | 29 (20%) | 47 (16%) |
| No, n (%) | NA | NA | NA | NA | NA | NA | 127 (88%) | 119 (80%) | 246 (84%) |
| >50% reduction in monthly seizure frequency relative to baseline | |||||||||
| Patients with available data, n (%) | NA | NA | NA | 157 (86%) | 153 (82%) | 310 (84%) | 152 (84%) | 149 (80%) | 301 (82%) |
| Yes, n (%) | NA | NA | NA | 43 (27%) | 65 (42%) | 108 (35%) | 60 (39%) | 68 (46%) | 128 (43%) |
| No, n (%) | NA | NA | NA | 114 (73%) | 88 (58%) | 202 (65%) | 92 (61%) | 81 (54%) | 173 (57%) |
| SF-12v2‡ | |||||||||
| Patients with available data, n (%) | 181 (99%) | 185 (99%) | 366 (99%) | 142 (78%) | 134 (72%) | 276 (75%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean Physical Component Summary score (SD; range) | 38·8 (11·9;13·9–65·6) | 40·5 (12·4;13·4–65·9) | 39·7 (12·2;13·4–66·0) | 38·8 (11·4;13·1–59·5) | 41·5 (13·4;15·9–66·7) | 40·1 (12·4;13·1–66·7) | 38·0 (12·6;10·4–63·7) | 41·5 (13·4;12·2–67·3) | 39·8 (13·1;10·4–67·3) |
| Mean Mental Component Summary score (SD; range) | 37·9 (11·4;16·9–68·1) | 37·7 (12·2;13·4–67·6) | 37·8 (11·8;13·4–68·1) | 37·5 (12·1;10·5–63·0) | 40·3 (11·7;17·4–67·5) | 38·8 (12·0;10·5–67·5) | 39·5 (11·8;11·3–62·9) | 41·5 (12·8;13·9–65·7) | 40·5 (12·4;11·3–65·7) |
| EQ-5D-5L visual analogue scale‡ | |||||||||
| Patients with available data, n (%) | 181 (99%) | 182 (98%) | 363 (99%) | 143 (79%) | 135 (73%) | 278 (76%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean score (SD; range) | 54·9 (21·9;10–100) | 56·2 (24·1;1–100) | 55·5 (23·0;1–100) | 50·9 (23·1;0–100) | 58·8 (24·4;0–100) | 54·7 (24·0;0–100) | 53·4 (22·6;5–100) | 61·1 (24·0;5–100) | 57·3 (23·6;5–100) |
| WSAS | |||||||||
| Patients with available data, n (%) | 181 (99%) | 185 (99%) | 366 (99%) | 143 (79%) | 135 (73%) | 278 (76%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean score§ (SD; range) | 22·9 (10·5;0–40) | 22·5 (10·5;0–40) | 22·7 (10·5;0–40) | 22·7 (11·9;0–40) | 17·8 (13·1;0–40) | 20·3 (12·7;0–40) | 21·1 (12·7;0–40) | 16·4 (13·1;0–40) | 18·7 (13·1;0–40) |
| GAD-7 scale | |||||||||
| Patients with available data, n (%) | 182 (100%) | 186 (100%) | 368 (100%) | 143 (79%) | 135 (73%) | 278 (76%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean score¶ (SD; range) | 10·0 (6·2;0–21) | 9·6 (6·2;0–21) | 9·8 (6·2;0–21) | 10·5 (6·3;0–21) | 8·1 (6·5;0–21) | 9·4 (6·5;0–21) | 9·3 (6·1;0–21) | 8·2 (6·0; 0–21) | 8·8 (6·1;0–21) |
| PHQ-9 | |||||||||
| Patients with available data, n (%) | 181 (99%) | 186 (100%) | 367 (100%) | 142 (78%) | 135 (73%) | 277 (75%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean score‖ (SD; range) | 12·6 (6·5;0–26) | 12·3 (6·7;0–27) | 12·4 (6·6;0–27) | 12·9 (7·0;0–27) | 11·2 (7·4;0–27) | 12·1 (7·2;0–27) | 11·7 (6·7;0–26) | 10·5 (7·5;0–26) | 11·1 (7·1;0–26) |
| CORE-10 | |||||||||
| Patients with available data, n (%) | 182 (100%) | 186 (100%) | 368 (100%) | 142 (78%) | 135 (73%) | 277 (75%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean score§ (SD; range) | 18·2 (6·3;4–34) | 18·2 (6·7;4–32) | 18·2 (6·5;4–34) | 18·6 (6·6;2–34) | 17·2 (7·1;0–39) | 17·9 (6·9;0–39) | 18·1 (6·6;3–33) | 16·6 (6·8;1–38) | 17·3 (6·7;1–38) |
| Modified PHQ-15 | |||||||||
| Patients with available data, n (%) | 181 (99%) | 183 (98%) | 364 (99%) | 140 (77%) | 135 (73%) | 275 (75%) | 145 (80%) | 147 (79%) | 292 (79%) |
| Mean score** (SD; range) | 16·7 (6·2;2–30) | 16·7 (6·8;2–30) | 16·7 (6·5;2–30) | 16·8 (6·7;0–29) | 14·9 (7·4;0–28) | 15·9 (7·1;0–29) | 15·9 (6·9;0–29) | 14·1 (7·7;0–28) | 15·0 (7·4;0–29) |
| Clinical global impression of improvement†† | |||||||||
| Patients with available data, n (%) | NA | NA | NA | 140 (77%) | 135 (73%) | 275 (75%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean self-reported change score (SD; range) | NA | NA | NA | 3·4 (1·6;0–6) | 4·2 (1·3;0–6) | 3·8 (1·5;0–6) | 3·6 (1·8;0–6) | 4·3 (1·5;0–6) | 4·0 (1·7;0–6) |
| Patients with available data, n (%) | NA | NA | NA | NA | NA | NA | 162 (89%) | 161 (87%) | 323 (88%) |
| Mean clinician-rated change score (SD; range) | NA | NA | NA | NA | NA | NA | 3·8 (1·3;0–6) | 4·4 (1·2;0–6) | 4·1 (1·3;0–6) |
| Patient satisfaction with treatment‡‡ | |||||||||
| Patients with available data, n (%) | NA | NA | NA | 140 (77%) | 135 (73%) | 275 (75%) | 145 (80%) | 148 (80%) | 293 (80%) |
| Mean satisfaction score (SD; range) | NA | NA | NA | 3·8 (2·0;0–6) | 5·1 (1·3;0–6) | 4·4 (1·8;0–6) | 4·2 (2·0;0–6) | 5·2 (1·4;0–6) | 4·7 (1·8;0–6) |
CBT=cognitive behavioural therapy. SF-12v2=12-item Short Form 12 Survey–version 2. EQ-5D-5L=EuroQoL-5 Dimensions-5 Level scale. WSAS=Work and Social Adjustment Scale. GAD-7=Generalised Anxiety Disorder seven-item. PHQ-9=Patient Health Questionnaire nine-item. CORE-10=Clinical Outcomes in Routine Evaluation-10. PHQ-15=Patient Health Questionnaire fifteen-item.
*
Measured on a 7-point scale (1=very mild; 7=very severe).
†
Measured on a 7-point scale (1=no bother at all; 7=very bothersome).
‡
Measured on a 100 point scale (0=worst health; 100=best health).
§
Possible range 0–40.
¶
Possible range 0–21.
‖
Possible range 0–27.
**
Possible range 0–30.
††
Change scores measured on a 7-point scale (0=very much worse; 6=very much better).
‡‡
Measured on a 7-point scale (0=very dissatisfied; 6=very satisfied).