Comparing Different Treatments in Reducing Dissociative Seizure Occurrence
NCT ID: NCT02325544
Last Updated: 2020-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
368 participants
INTERVENTIONAL
2014-10-01
2018-06-30
Brief Summary
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About 12-20% of patients who attend neurology or specialist epilepsy clinics because of seizures do not in fact have epilepsy. Most of these people have what are referred to as dissociative (non-epileptic) seizures (DS). This means that they have episodes that resemble epileptic seizures but which have no medical reason for their occurrence and instead are due to psychological factors. In younger adults DS are about four times more common in women than men. A high percentage of these people will have other psychological or psychiatric problems and may have other medically unexplained symptoms. It is generally thought that people with DS will benefit from psychological treatments. However, studies on this have been small or have not compared the psychological therapy with the treatment people normally receive (standardised medical care). There is some evidence that cognitive behavioural therapy (CBT), which is a widely accepted talking therapy that focuses on the person's thoughts, emotions and behaviour, as well as considering the physical reactions and sensations that may occur in people's bodies, may lead to a reduction in how often people have DS. The investigators have previously developed a CBT package for people with DS. In a relatively small study by our group, published in 2010, people receiving CBT overall showed greater reduction in how often they had their DS. The investigators are now conducting a larger study, across several different hospitals, to obtain more definite results about the effectiveness of our CBT approach for DS.
The investigators aim to invite \~ 500 adult patients with DS (but without current active epilepsy), who have been given their diagnosis by a neurologist or specialist in epilepsy, to take part in their study. Up to 698 might be invited if insufficient patients are progressing to the RCT.
The investigators will collect initial information about these people and ask them to keep a record of how often they have their DS following diagnosis. Three months after the diagnosis, those who have agreed to take part in the study will be seen by a psychiatrist, who will undertake a psychiatric assessment and ask them about factors which may have led to the development of their DS. Patients who have continued to have DS in the previous 8 weeks and who meet other eligibility criteria and are willing to take part in the trial, will be randomly allocated to standardised medical care or CBT (plus standardised medical care) as further treatment for their seizures. These people will be asked to continue to complete seizure diaries and questionnaires, provide regular seizure frequency data following receipt of DS diagnosis and will need to be willing to attend weekly/fortnightly sessions if allocated to CBT. The investigators initially aim to randomise 298 people (149 to each study arm) although now allow for up to 356 to account for loss to follow-up.
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Detailed Description
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In the observational phase patients will be given their diagnosis of dissociative seizures by a neurologist/epilepsy specialist and will be told about the CODES study. In addition to a leaflet on dissociative seizures they will, if interested in the study and are willing to be referred to a psychiatrist, be given an information sheet about DS and about the study and the doctor will document their agreement to be contacted by a research nurse/worker. This person will arrange to contact them, clarify study details, obtain informed consent, collect demographic details and explain seizure diary recording. They will then contact the patient fortnightly (bi-weekly)for seizure data. The investigators initially aim to recruit \~500 patients at this stage.
After 3 months the patient will be reviewed by a neuropsychiatrist/ liaison psychiatrist/ psychiatrist with interest in DS who will undertake a clinical assessment, review the patient's eligibility for the interventional phase of the study and if eligible will explain the RCT. Patients will be given a further leaflet on DS and a Participant Information Sheet and the psychiatrist will document interested patients' willingness to again be contacted by a research nurse/worker. That person will then explain the RCT in greater detail, obtain informed consent, undertake a baseline assessment including a MINI and instruct patients to keep seizure records for which data will be collected fortnightly. .Randomisation of between 298 and 356 people (depending on follow-up rates) to either CBT plus standardised medical care (SMC) or to SMC alone will occur after informed consent has been obtained and baseline measures have been collected. The stratification factor will be liaison/neuropsychiatry centre. The research workers and trial statistician will remain blinded. Computer-generated randomisation will be conducted remotely (for more details see www.ctu.co.uk - randomisation - advanced) by the King's Clinical Trials Unit (KCTU) at the Institute of Psychiatry, Psychology and Neuroscience. The investigators will maintain strict allocation concealment. The investigators will test the RWs' blinding by asking them to record when they think that allocation was revealed and record the group to which they thought patients had been allocated.
CBT will be delivered over 12 sessions (each approximately one hour in length) over a 4-5 month period with one booster session at 9 months post randomisation. The investigators' treatment model has been developed from a single case study, trialled in an open label study and then in a Pilot RCT. The model is based on the two-process fear escape-avoidance model and conceptualises DS as dissociative responses to cues (cognitive/emotional/physiological or environmental) that may (but not in all cases) have been associated with profoundly distressing or life-threatening experiences, such as abuse or trauma, at an earlier stage in the person's life and which have previously produced intolerable feelings of fear and distress. Written handouts supplement the content of face-to face therapy sessions. The investigators will record therapy sessions and undertake treatment fidelity ratings. Therapists will receive training prior to treating study patients.
Neurologists and psychiatrists with an interest in DS will deliver standardised medical care (SMC). They will have guidelines as to the delivery of standardised medical care. Information leaflets will be given to the patients. The research team will provide this material. SMC by psychiatrists will include support, consideration of psychiatric comorbidities and any associated drug treatment and general review but no CBT techniques.
The investigators allow for some local variation in the number of neurology and psychiatry SMC sessions after randomisation.
Measures will be recorded at baseline, six months and 12 months post randomisation. In addition to quantitative analyses, a nested qualitative study will investigate experiences of CBT and SMC and factors acting as facilitators and barriers to participation, as well as of healthcare professionals'.experiences of delivering the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBT+SMC
12 sessions of Cognitive Behavioural Therapy adapted for DS (plus one booster session) plus standardised medical care
Cognitive Behavioral Therapy
12 sessions of CBT (over 4-5 months) +1 booster session. Guided by a therapy manual and patient handouts; will involve setting homework tasks. Although treatment is manualised, it allows treatment to be formulation-based i.e. tailored to the person.
Standardised medical as described in other intervention.
Standardized Medical Care
Delivered by neurologists/ psychiatrists - both will be involved in discussing diagnosis. It will Include an information sheet about dissociative seizures and direction to self-help websites, general information provision about management of DS and support, consideration of psychiatric comorbidities / associated drug treatment and general review but no CBT techniques.
SMC
Standardised medical care provide by neurologist and/or psychiatrist
Standardized Medical Care
Delivered by neurologists/ psychiatrists - both will be involved in discussing diagnosis. It will Include an information sheet about dissociative seizures and direction to self-help websites, general information provision about management of DS and support, consideration of psychiatric comorbidities / associated drug treatment and general review but no CBT techniques.
Interventions
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Cognitive Behavioral Therapy
12 sessions of CBT (over 4-5 months) +1 booster session. Guided by a therapy manual and patient handouts; will involve setting homework tasks. Although treatment is manualised, it allows treatment to be formulation-based i.e. tailored to the person.
Standardised medical as described in other intervention.
Standardized Medical Care
Delivered by neurologists/ psychiatrists - both will be involved in discussing diagnosis. It will Include an information sheet about dissociative seizures and direction to self-help websites, general information provision about management of DS and support, consideration of psychiatric comorbidities / associated drug treatment and general review but no CBT techniques.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ability to complete seizure diaries and questionnaires;
* willingness to complete seizure diaries regularly and undergo psychiatric assessment 3 months after DS diagnosis;
* no documented history of intellectual disabilities;
* ability to give written informed consent.
* adults (≥18yrs) with DS initially recruited at point of diagnosis;
* willingness to continue to complete seizure diaries and questionnaires;
* provision of regular seizure frequency data following receipt of DS diagnosis;
* willingness to attend weekly/fortnightly sessions if randomised to CBT
* both clinician and patient think that randomisation is acceptable
* ability to give written informed consent.
Exclusion Criteria
* inability to keep seizure records or complete questionnaires independently;
* meeting DSM-IV criteria for current drug/alcohol dependence;
* insufficient command of English to later undergo CBT without an interpreter or to complete questionnaires independently. Reasons for this include the need to self-rate secondary outcomes using scales not validated for non-English speaking populations, the considerable cost and uncertainty of being able reliably to engage sufficiently competent interpreters, and the need to demonstrate the delivery of therapy in terms of quality and manual adherence.
* having previously undergone a CBT-based treatment for dissociative seizures at a trial participating centre
* currently having CBT for another disorder, if this will not have ended by the time that the psychiatric assessment takes place.
* current epileptic seizures as well as DS, for reasons given above;
* not having had any DS in the 8 weeks prior to the psychiatric assessment, 3 months post diagnosis;
* having previously undergone a CBT-based treatment for dissociative seizures at a trial participating centre
* currently having CBT for another disorder
* active psychosis;
* meeting DSM-IV criteria for current drug/alcohol dependence; this may exacerbate symptoms/alter psychiatric state and health service use and affect recording of seizures;
* current benzodiazepine use exceeding the equivalent of 10mg diazepam/day;
* the patient is thought to be at imminent risk of self harm, after (neuro)psychiatric assessment or structured psychiatric assessment by the Research Worker with the MINI, followed by consultation with the psychiatrist.
* known diagnosis of Factitious Disorder
18 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
University of Sheffield
OTHER
University of Sussex
OTHER
South London and Maudsley NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Laura H Goldstein, PhD MPhil
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Derbyshire Community Health Services Nhs Trust
Bakewell, , United Kingdom
Birmingham and Solihull Mental Health Nhs Foundation Trust
Birmingham, , United Kingdom
University Hospital Birmingham Nhs Foundation Trust
Birmingham, , United Kingdom
Berkshire Healthcare Nhs Foundation Trust
Bracknell, , United Kingdom
Brighton and Sussex University Hospitals Nhs Trust
Brighton, , United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, , United Kingdom
Cambridgeshire and Peterborough Nhs Foundation Trust
Cambridge, , United Kingdom
East Kent Hospitals University Nhs Foundation Trust
Canterbury, , United Kingdom
Cardiff and Vale University Local Health Board
Cardiff, , United Kingdom
Chesterfield Royal Hospital Nhs Foundation Trust
Chesterfield, , United Kingdom
Dartford and Gravesham Nhs Trust
Dartford, , United Kingdom
Derbyshire Healthcare Nhs Foundation Trust
Derby, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Medway Nhs Foundation Trust
Gillingham, , United Kingdom
Leeds Partnerships Nhs Foundation Trust
Leeds, , United Kingdom
Leeds Teaching Hospitals Nhs Trust
Leeds, , United Kingdom
Barts and the London Nhs Trust
London, , United Kingdom
East London Nhs Foundation Trust
London, , United Kingdom
University College London Hospitals Nhs Foundation Trust
London, , United Kingdom
Royal Free Hampstead Nhs Trust
London, , United Kingdom
Guy'S and St Thomas' Nhs Foundation Trust
London, , United Kingdom
Lewisham Healthcare Nhs Trust
London, , United Kingdom
South London and Maudsley NHS Foundation Trust
London, , United Kingdom
King'S College Hospital Nhs Foundation Trust
London, , United Kingdom
St George'S Healthcare Nhs Trust
London, , United Kingdom
South West London and St George'S Mental Health Nhs Trust
London, , United Kingdom
Imperial College Healthcare Nhs Trust
London, , United Kingdom
Maidstone and Tunbridge Wells Nhs Trust
Maidstone, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Trust
Newcastle, , United Kingdom
Northumberland Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Royal Berkshire Nhs Foundation Trust
Reading, , United Kingdom
East Sussex Healthcare Nhs Trust
Saint Leonards-on-Sea, , United Kingdom
Sheffield Health and Social Care Nhs Foundation Trust
Sheffield, , United Kingdom
Sheffield Teaching Hospitals Nhs Foundation Trust
Sheffield, , United Kingdom
University Hospital Southhampton NHS Trust
Southampton, , United Kingdom
Croydon Health Services Nhs Trust
Thornton Heath, , United Kingdom
West London Mental Health Nhs Foundation Trust
Uxbridge, , United Kingdom
Kent and Medway Nhs and Social Care Partnership Trust
West Malling, , United Kingdom
Western Sussex Hospitals Nhs Trust
Worthing, , United Kingdom
Sussex Partnership Nhs Foundation Trust
Worthing, , United Kingdom
Countries
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References
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Goldstein LH, Chalder T, Chigwedere C, Khondoker MR, Moriarty J, Toone BK, Mellers JD. Cognitive-behavioral therapy for psychogenic nonepileptic seizures: a pilot RCT. Neurology. 2010 Jun 15;74(24):1986-94. doi: 10.1212/WNL.0b013e3181e39658.
Goldstein LH, Mellers JD, Landau S, Stone J, Carson A, Medford N, Reuber M, Richardson M, McCrone P, Murray J, Chalder T. COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol. BMC Neurol. 2015 Jun 27;15:98. doi: 10.1186/s12883-015-0350-0.
Robinson EJ, Goldstein LH, McCrone P, Perdue I, Chalder T, Mellers JDC, Richardson MP, Murray J, Reuber M, Medford N, Stone J, Carson A, Landau S. COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial. Trials. 2017 Jun 6;18(1):258. doi: 10.1186/s13063-017-2006-4.
Jordan H, Feehan S, Perdue I, Murray J, Goldstein LH. Exploring psychiatrists' perspectives of working with patients with dissociative seizures in the UK healthcare system as part of the CODES trial: a qualitative study. BMJ Open. 2019 May 9;9(5):e026493. doi: 10.1136/bmjopen-2018-026493.
Goldstein LH, Robinson EJ, Reuber M, Chalder T, Callaghan H, Eastwood C, Landau S, McCrone P, Medford N, Mellers JDC, Moore M, Mosweu I, Murray J, Perdue I, Pilecka I, Richardson MP, Carson A, Stone J; CODES Study Group. Characteristics of 698 patients with dissociative seizures: A UK multicenter study. Epilepsia. 2019 Nov;60(11):2182-2193. doi: 10.1111/epi.16350. Epub 2019 Oct 13.
Goldstein LH, Robinson EJ, Mellers JDC, Stone J, Carson A, Chalder T, Reuber M, Eastwood C, Landau S, McCrone P, Moore M, Mosweu I, Murray J, Perdue I, Pilecka I, Richardson MP, Medford N; CODES Study Group. Psychological and demographic characteristics of 368 patients with dissociative seizures: data from the CODES cohort. Psychol Med. 2021 Oct;51(14):2433-2445. doi: 10.1017/S0033291720001051. Epub 2020 May 11.
Wilkinson M, Day E, Purnell J, Pilecka I, Perdue I, Murray J, Hunter EM, Goldstein LH. The experiences of therapists providing cognitive behavioral therapy (CBT) for dissociative seizures in the CODES randomized controlled trial: A qualitative study. Epilepsy Behav. 2020 Apr;105:106943. doi: 10.1016/j.yebeh.2020.106943. Epub 2020 Feb 18.
Read J, Jordan H, Perdue I, Purnell J, Murray J, Chalder T, Reuber M, Stone J, Goldstein LH. The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study. Epilepsy Behav. 2020 Oct;111:107230. doi: 10.1016/j.yebeh.2020.107230. Epub 2020 Jul 5.
Stone J, Callaghan H, Robinson EJ, Carson A, Reuber M, Chalder T, Perdue I, Goldstein LH. Predicting first attendance at psychiatry appointments in patients with dissociative seizures. Seizure. 2020 Jan;74:93-98. doi: 10.1016/j.seizure.2019.11.014. Epub 2019 Nov 28.
Goldstein LH, Robinson EJ, Mellers JDC, Stone J, Carson A, Reuber M, Medford N, McCrone P, Murray J, Richardson MP, Pilecka I, Eastwood C, Moore M, Mosweu I, Perdue I, Landau S, Chalder T; CODES study group. Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial. Lancet Psychiatry. 2020 Jun;7(6):491-505. doi: 10.1016/S2215-0366(20)30128-0. Epub 2020 May 20.
Goldstein LH, Robinson EJ, Chalder T, Stone J, Reuber M, Medford N, Carson A, Moore M, Landau S. Moderators of cognitive behavioural therapy treatment effects and predictors of outcome in the CODES randomised controlled trial for adults with dissociative seizures. J Psychosom Res. 2022 Jul;158:110921. doi: 10.1016/j.jpsychores.2022.110921. Epub 2022 Apr 19.
Goldstein LH, Robinson EJ, Pilecka I, Perdue I, Mosweu I, Read J, Jordan H, Wilkinson M, Rawlings G, Feehan SJ, Callaghan H, Day E, Purnell J, Baldellou Lopez M, Brockington A, Burness C, Poole NA, Eastwood C, Moore M, Mellers JD, Stone J, Carson A, Medford N, Reuber M, McCrone P, Murray J, Richardson MP, Landau S, Chalder T. Cognitive-behavioural therapy compared with standardised medical care for adults with dissociative non-epileptic seizures: the CODES RCT. Health Technol Assess. 2021 Jun;25(43):1-144. doi: 10.3310/hta25430.
Related Links
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CODES study website
Other Identifiers
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CSP 136836
Identifier Type: -
Identifier Source: org_study_id
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