Abstract
PurposeThe CODES Trial for adults with dissociative seizures had a predesignated 12-month post-randomisation follow-up point for outcome evaluation. We undertook an exploratory, unplanned, secondary analysis to evaluate the effectiveness of cognitive behavioural therapy plus standardised medical care (CBT+SMC) compared to SMC alone at 6 months post-randomisation, i.e., closer to the end of treatment. MethodsThe analysis of 6-month data followed our previous method of using multiple imputation and an intention-to-treat approach to analyse variables 12 months post-randomisation. ResultsThe original trial primary outcome of monthly seizure frequency showed greater benefit from CBT+SMC than SMC-alone at 6 months (at p < 0.05). Of 13 comparable previously-defined secondary outcomes, 12 showed a significant between group effect (p < 0.05) in favour of the CBT intervention at 6 months. The average effect size of the comparable previously-defined primary and secondary continuous outcomes was 0.33 at 6 months vs 0.26 at 12 months. The estimated Incidence Rate Ratio (IRR) quantifying monthly seizure reduction was IRR = 0.72 (95%CI from 0.55 to 0.93) at 6 months compared to IRR = 0.78 at 12 months. ConclusionDS-specific CBT (plus SMC) produced evidence of significant benefits at 6 months post- randomisation (around which time CBT was complete) compared to SMC alone; for the majority of these outcomes, better results following CBT (plus SMC) had previously been reported at 12 months. Our pattern of results suggests that short- and longer-term follow-ups are necessary to understand treatment effects in this disorder. Studies only providing short-term follow-up data should be interpreted with caution.
Highlights
While psychological interventions are considered to be the treatment of choice for adults with dissociative seizures (DS), evidence for such treatments was limited prior to the ‘Cognitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES)’ Trial
While a CONSORT flow-chart leading to the 12-month follow-up in the main trial can be found in our main trial reports [2,3], Fig. 1 shows the number of participants who contributed to the 6-month outcomes which are considered in this secondary analysis
The Cognitive Behavioural Therapy (CBT) effect in terms of >50% reduction in monthly seizure frequency relative to baseline at 6 months was odds ratios (ORs) = 2.17 (95%CI from 1.34 to 3.52) compared to OR = 1.27 at 12 months [2,3]
Summary
While psychological interventions are considered to be the treatment of choice for adults with dissociative seizures (DS), evidence for such treatments was limited prior to the ‘Cognitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES)’ Trial.
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