COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures CODES: a multicentre randomised controlled trial protocolReportar como inadecuado




COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures CODES: a multicentre randomised controlled trial protocol - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Neurology

, 15:98

First Online: 27 June 2015Received: 27 May 2015Accepted: 07 June 2015

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 ISRCTN05681227

ClinicalTrials.gov NCT02325544

KeywordsDissociative seizures Psychogenic non-epileptic seizures Randomised controlled trial Cognitive behavioural therapy Clinical trial Conversion disorder AbbreviationsCBTCognitive behavioural therapy

DSDissociative seizures

SMCStandardised medical care

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