Table 3.
Comparison of outcome measures between the CBT plus standardised medical care and standardised medical care alone groups at 12 months derived by multiple imputation (100 imputations)
| Estimated mean difference*(95% CI) | Standardised group difference (95% CI) | p value | |
|---|---|---|---|
| Primary outcome | |||
| Monthly seizure frequency in last 4 weeks | NA | 0·78 (0·56 to 1·09)† | 0·144 |
| Secondary outcomes | |||
| Seizure severity score | −0·11 (−0·50 to 0·29) | −0·07 (−0·31 to 0·18) | 0·593 |
| Seizure bothersomeness severity score | −0·53 (−0·97 to −0·08) | −0·30 (−0·56 to −0·05) | 0·020‡ |
| Longest period of seizure freedom in past 6 months (days) | NA | 1·64 (1·22 to 2·20)† | 0·001† |
| Seizure freedom in last 3 months of trial | NA | 1·77 (0·93 to 3·37)§ | 0·083 |
| >50% reduction in monthly seizure frequency relative to baseline | NA | 1·27 (0·80 to 2·02)§ | 0·313 |
| Physical Component Summary score (SF-12v2) | 1·78 (−0·37 to 3·92) | 0·15 (−0·03 to 0·32) | 0·105 |
| Mental Component Summary score (SF-12v2) | 2·22 (−0·30 to 4·75) | 0·15 (−0·03 to 0·33) | 0·084 |
| EQ-5D-5L visual analogue scale | 6·16 (1·48 to 10·84) | 0·27 (0·06 to 0·47) | 0·010† |
| Impact on functioning (WSAS) | −4·12 (−6·35 to −1·89) | −0·39 (−0·61 to −0·18) | <0·001† |
| Anxiety (GAD-7) | −1·09 (−2·27 to 0·09) | −0·18 (−0·37 to 0·01) | 0·069 |
| Depression (PHQ-9) | −1·10 (−2·41 to 0·21) | −0·17 (−0·37 to 0·03) | 0·099 |
| Distress (CORE-10) | −1·65 (−2·96 to −0·35) | −0·25 (−0·45 to −0·05) | 0·013‡ |
| Other somatic symptoms (modified PHQ-15) | −1·67 (−2·90 to −0·44) | −0·26 (−0·45 to −0·07) | 0·008‡ |
| Self-reported change (CGI score) | 0·66 (0·26 to 1·04) | 0·39 (0·16 to 0·62) | 0·001‡ |
| Clinician-rated change (CGI score) | 0·47 (0·21 to 0·73) | 0·37 (0·17 to 0·57) | <0·001‡ |
| Patient-reported satisfaction with treatment | 0·90 (0·48 to 1·31) | 0·50 (0·27 to 0·73) | <0·001‡ |
p values not adjusted for multiple testing. Standardised group differences between 0·35 and 0·65 were considered moderate. NA=not applicable. SF-12v2=12-item Short Form 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. CGI=Clinical Global Impression.
Using original scales.
Treatment effects for count outcomes are presented as incidence rate ratios.
Statistically significant at 5% level (not accounting for multiple testing).
Treatment effects for binary outcomes are presented as odds ratios.