Comparing Different Treatments in Reducing Dissociative Seizure Occurrence
关键词
抽象
描述
There is an initial observational phase to this study followed by a parallel group, two-arm multi-centre pragmatic randomised controlled trial (interventional phase).
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.
日期
| 最后验证: | 01/31/2016 |
| 首次提交: | 12/14/2014 |
| 提交的预估入学人数: | 12/23/2014 |
| 首次发布: | 12/24/2014 |
| 上次提交的更新: | 03/22/2020 |
| 最近更新发布: | 03/24/2020 |
| 实际学习开始日期: | 09/30/2014 |
| 预计主要完成日期: | 05/30/2017 |
| 预计完成日期: | 05/31/2018 |
状况或疾病
干预/治疗
Behavioral: CBT+SMC
Behavioral: Standardized Medical Care
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: CBT+SMC 12 sessions of Cognitive Behavioural Therapy adapted for DS (plus one booster session) plus standardised medical care | Behavioral: CBT+SMC 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. |
| Active Comparator: SMC Standardised medical care provide by neurologist and/or psychiatrist |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. The inclusion criteria applied at the initial recruitment stage will be as follows: - adults (≥18yrs) 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 - 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. 2. Inclusion criteria evaluated at the randomisation stage will be as follows: - 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: The exclusion criteria applied at the initial recruitment stage will be as follows: - having a diagnosis of current epileptic seizures as well as DS. Patients with both DS and ES have been included in small studies but there is no method for verifying that patients can accurately differentiate between epileptic seizures and DS; - 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. Exclusion criteria evaluated at the randomisation stage will be as follows: - 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 |
结果
主要结果指标
1. Change in seizure frequency [Outcome assessed at 12 month post randomisation,]
次要成果指标
1. Change in informant rating [Outcome assessed at 12 month post randomisation only]
2. Change in self-rated seizure severity [Outcome assessed at 12 month post randomisation only]
3. Seizure freedom [Outcome assessed at 12 month post randomisation only]
4. >50% reduction in seizure frequency [Outcome assessed at 12 month post randomisation only]
5. Change in Quality of life (QoL) [Outcome assessed at 12 month post randomisation only]
6. Change in QALYs [Outcome assessed at 12 month post randomisation only]
7. Change in psychosocial functioning [Outcome assessed at 12 month post randomisation only]
8. Change in psychiatric symptoms and psychological distress [Outcome assessed at 12 month post randomisation only]
9. Change in patients self-rated global outcome and satisfaction with treatment [Outcome assessed at 12 month post randomisation only]
10. Clinician rating of change [Outcome assessed at 12 month post randomisation only]
11. Change in health service use and informal care (self-report) [Outcome assessed at 12 month post randomisation only]
12. Change in health service use [Outcome assessed at 12 months post randomisation]
