COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol

Abstract

BackgroundThe evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures (DS) is currently extremely limited, although data from two small pilot randomised controlled trials (RCTs), including from our group, suggest that Cognitive Behavioural Therapy (CBT) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning.Methods/DesignThe study is a multicentre, pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus standardised medical care (SMC) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes. In the initial screening phase, patients with DS will receive their diagnosis from a neurologist/epilepsy specialist. If patients are eligible and interested following the provision of study information and a booklet about DS, they will consent to provide demographic information and fortnightly data about their seizures, and agree to see a psychiatrist three months later. We aim to recruit ~500 patients to this screening stage. After a review three months later by a psychiatrist, those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone. If they are interested in participating, they will be given a further booklet on DS and study information. A research worker will see them to obtain their informed consent to take part in the RCT. We aim to randomise 298 people (149 to each arm). In addition to a baseline assessment, data will be collected at 6 and 12 months post randomisation. Our primary outcome is monthly seizure frequency in the preceding month. Secondary outcomes include seizure severity, measures of seizure freedom and reduction, psychological distress and psychosocial functioning, quality of life, health service use, cost effectiveness and adverse events. We will include a nested qualitative study to evaluate participants’ views of the intervention and factors that acted as facilitators and barriers to participation.DiscussionThis study will be the first adequately powered evaluation of CBT for this patient group and offers the potential to provide an evidence base for treating this patient group.Trial registrationCurrent Controlled Trials ISRCTN05681227ClinicalTrials.gov NCT02325544

Access to diagnostic and therapeutic facilities for psychogenic nonepileptic seizures: An international survey by the ILAE PNES Task Force

“…The results of a fully powered trial of cognitive behavioral therapy (CBT) for PNES currently being conducted in the United Kingdom and the availability of a manualized therapy for PNES should encourage more providers to facilitate access to this treatment modality. 29,30 Only 5% thought antidepressants to be the best option, reflecting the limited evidence for the effectiveness of medications for PNES. 31 Of note, 40% of Japanese respondents thought that "environmental control" was most effective.…”

Understanding psychogenic nonepileptic seizures—Phenomenology, semiology and the Integrative Cognitive Model

“…This means that future aetiological research will need to involve larger numbers patients with PNES. The impressive recruitment success of the multicentre CODES study in the United Kingdom (a randomised controlled Cognitive Behaviour Therapy treatment trial to which over 500 patients have been recruited so far [68]) demonstrates that these sort of studies are feasible if researchers collaborate and funders can be persuaded to invest in the improvement of a common, costly and under-researched disorder.…”

Explaining dissociative seizures: a neuropsychological perspective

“…For many patients, however, dissociative seizures occur in the context of complex physiological difficulties and/or family dynamics, which are best addressed within a multidisciplinary team approach, although this may not always be feasible in a resource-limited setting. The outcome of large randomised control trials investigating the effectiveness of cognitive behavioural therapy in people with dissociative seizures will be of particular future interest 16. Given the encouraging results of previous pilot trials,17 18 cognitive behavioural therapy might offer a much-needed, viable treatment for people with this condition.…”