Dissociative seizures (also referred to as psychogenic nonepileptic seizures) Nervous System Diseases
Conditions
Interventions
How the CBT will be delivered:
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 randomis
engagement and rationale giving
teaching and use of seizure control techniques
reducing avoidance exposure technique
dealing with seizure-related cognitions and emotions
and relapse prevention. The treatment is manualised, which is important for subsequent rollout, but the structure allows treatment to be formulation-based so that particular issues raised in therapy t
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/05/2015: Inclusion criteria applied at the initial recruitment stage: 1. Adults (=18 years) with DS that have continued to occur within the previous 8 weeks and have been confirmed by video EEG telemetry or, where not achievable, clinical consensus; patients who have chronic DS can be included if they have been seen by the relevant Study Neurologist who has reviewed their diagnosis and communicated this to them according to the study protocol 2. Ability to complete seizure diaries and questionnaires 3. Willingness to complete seizure diaries regularly and undergo psychiatric assessment 3 months after DS diagnosis 4. No documented history of intellectual disabilities 5. Ability to give written informed consent Inclusion criteria evaluated at the randomisation stage: 1. Adults (=18 years) with DS initially recruited at point of diagnosis; 2. Willingness to continue to complete seizure diaries and questionnaires; 3. Having provided regular seizure frequency data to research team following receipt of DS diagnosis; 4. Willingness to attend weekly/fortnightly sessions if randomised to CBT 5. Both clinician and patient agree that randomisation is acceptable 6. Ability to give written informed consent; Previous inclusion criteria: Inclusion criteria applied at the initial recruitment phase: 1. Adults (=18 years) with DS confirmed by video EEG telemetry or, where not achievable, clinical consensus 2. Patients who have chronic DS can be included if they have been seen by the relevant study neurologist who has reviewed their diagnosis and communicated this to them according to the study protocol 3. Ability to complete seizure diaries and questionnaires 4. Willingness to complete seizure diaries regularly and undergo psychiatric assessment 3 months after DS diagnosis 5. No documented history of intellectual disabilities 6. Ability to give written informed consent Inclusion criteria evaluated at the randomisation phase: 1. Adults (=18 years) with DS initially recruited at point of diagnosis 2. Willingness to continue to complete seizure diaries and questionnaires 3. Provision of regular seizure frequency data following receipt of DS diagnosis 4. Willingness to attend weekly/fortnightly sessions if randomised to CBT 5. Both clinician and patient think that randomisation is acceptable 6. Ability to give written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/05/2015: Exclusion criteria applied at the initial recruitment stage: 1. Having a diagnosis of current epileptic seizures as well as DS 2. Inability to keep seizure records or complete questionnaires independently 3. Meeting DSM-IV criteria for current drug/alcohol dependence 4. Insufficient command of English to later undergo CBT without an interpreter or to complete questionnaires independently 5. Having previously undergone a CBT-based treatment for dissociative seizures at a trial participating centre 6. Currently having CBT for another disorder, if this will not have ended by the time that the psychiatric assessment takes place Exclusion criteria evaluated at the randomisation stage: 1. Current epileptic seizures as well as DS, for reasons given above 2. Not having had any DS in the 8 weeks prior to the psychiatric assessment, 3 months post diagnosis 3. Having previously undergone a CBT-based treatment for dissociative seizures at a trial participating centre 4. Currently having CBT for another disorder 5. Active psychosis 6. 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 7. Current benzodiazepine use exceeding the equivalent of 10mg diazepam/day 8. The patient is thought to be at imminent risk of self-harm, after psychiatric assessment or structured psychiatric assessment by the Research Worker with the MINI, followed by consultation with the psychiatrist 9. Known diagnosis of Factitious Disorder Previous exclusion criteria: Exclusion criteria applied at the initial recruitment phase: 1. Having a diagnosis of current epileptic seizures as well as DS 2. Inability to keep seizure records or complete questionnaires independently 3. Meeting DSM-IV criteria for current drug/alcohol dependence 4. Insufficient command of English to later undergo CBT without an interpreter or to complete questionnaires independently Exclusion criteria evaluated at the randomisation phase: 1. Current epileptic seizures as well as DS, for reasons given above 2. Not having had any DS in the 8 weeks prior to the psychiatric assessment, 3 months post diagnosis 3. Having previously undergone a CBT-based treatment for dissociative seizures at a trial participating centre 4. Currently having CBT for another disorder 5. Active psychosis 6. 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 7. Current benzodiazepine use exceeding the equivalent of 10 mg diazepam/day 8. The patient is thought to be at imminent risk of self-harm, after (neuro)psychiatric assessment and structured psychiatric assessment by the Research Worker with the MINI 9. Known diagnosis of Factitious Disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monthly DS frequency at 12 months post-randomisation. This is a continuous variable that comprises a count of seizures over a four-week exposure period and therefore will reflect all participants' outcomes, whether they improve or not during the study. Seizure frequency has been used as an outcome measure in other studies of psychological interventions for DS. Added 31/03/2020: Frequency will also be measured at baseline and 6 months post-randomisation but the outcome will be assessed at 12 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 31/03/2020: The following secondary outcome measures are collected at baseline, 6- and 12-month follow up (unless otherwise specified). The assessment of the outcomes is at 12 months only. 1. A rating by an informant as to whether, compared to study entry (i.e. time of diagnosis) the patient's seizure frequency is worse, the same, better or whether they are seizure free 2. Self-rated seizure severity and bothersomeness, measured using two items from the Seizure Severity Scale (Cramer et al., 2002), asking how severe and bothersome DS were in the past month 3. Seizure freedom: patients' self-reported longest period of seizure freedom in days, measured between the 6- and 12-month follow-up (and previous 6 months at baseline); and whether or not the patient is seizure free in the last 3 months of the trial 4. The number of patients in each group who at the 6- and 12-month follow-up show >50% reduction in seizure frequency, compared to baseline 5. Quality of life (QoL): a generic measure of health-related QoL, the SF-12v2 (Ware et al.,1996) to allow more direct comparison to be made with other disorders. This will also allow the calculation of QALYs, although the principal measure for doing that in this study is the EQ-5D-5L (EuroQol group, 1990), a 5-domain, 5-level, multi-attribute scale which will also be used. Added 31/03/2020: Relevant summary measures will be: SF-12v2 Physical Composite Scale (PCS), SF-12v2 Mental Health Composite Scale (MCS), and EQ-5D-5L visual analogue scale (VAS) of health today 6. Psychosocial functioning: the 5-item Work and Social Adjustment Scale (WSAS) (Mundt et al., 2002) to measure patients' own perceptions of the impact of DS on their functioning in terms of work, home management, social leisure and private leisure activities, family and other relationships 7. Psychiatric symptoms and psychological distress: anxiety, | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed