title: COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol.
abstract: BACKGROUND
  The 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
  The 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN05681227 ClinicalTrials.gov NCT02325544.
authors.affiliation: Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. laura.goldstein@kcl.ac.uk.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Goldstein
authors.affiliation: South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK. john.mellers@slam.nhs.uk.
authors.forename: John D C
authors.initials: JD
authors.lastname: Mellers
authors.affiliation: King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Biostatistics, De Crespigny Park, London, SE5 8AF, UK. sabine.landau@kcl.ac.uk.
authors.forename: Sabine
authors.initials: S
authors.lastname: Landau
authors.affiliation: Department of Clinical Neurosciences, Western General Hospital, Edinburgh, EH4 2XU, UK. jon.stone@ed.ac.uk.
authors.forename: Jon
authors.initials: J
authors.lastname: Stone
authors.affiliation: Department of Rehabilitation Medicine and Department of Clinical Neurosciences, Royal Edinburgh Hospital, Morningside Terrace, Edinburgh EH10 5HF, and University of Edinburgh, Edinburgh, UK. Alan.Carson@nhslothian.scot.nhs.uk.
authors.forename: Alan
authors.initials: A
authors.lastname: Carson
authors.affiliation: Clinical Imaging Sciences Centre, Brighton and Sussex Medical School, Falmer, Brighton, BN1 9RR, UK. n.medford@bsms.ac.uk.
authors.forename: Nick
authors.initials: N
authors.lastname: Medford
authors.affiliation: Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK. Markus.Reuber@sth.nhs.uk.
authors.forename: Markus
authors.initials: M
authors.lastname: Reuber
authors.affiliation: King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Basic and Clinical Neuroscience, De Crespigny Park, London, SE5 8AF, UK. mark.richardson@kcl.ac.uk.
authors.forename: Mark
authors.initials: M
authors.lastname: Richardson
authors.affiliation: King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Health Service and Population Research, De Crespigny Park, London, SE5 8AF, UK. paul.mccrone@kcl.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Health Service and Population Research, De Crespigny Park, London, SE5 8AF, UK. Joanna.murray@kcl.ac.uk.
authors.forename: Joanna
authors.initials: J
authors.lastname: Murray
authors.affiliation: King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, De Crespigny Park, London, SE5 8AF, UK. Trudie.chalder@kcl.ac.uk.
authors.forename: Trudie
authors.initials: T
authors.lastname: Chalder
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003291:Conversion Disorder / Q000150:complications / Q000191:economics / Q000523:psychology / Q000628:therapy*; D003362:Cost-Benefit Analysis; D004213:Dissociative Disorders / Q000150:complications / Q000191:economics / Q000523:psychology / Q000628:therapy*; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D017060:Patient Satisfaction; D011788:Quality of Life; D012640:Seizures / Q000191:economics / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome