COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures: a multicentre randomised controlled trial (CODES)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Dissociative seizures (also referred to as psychogenic nonepileptic seizures)
- Sponsor
- King's College London
- Enrollment
- 368
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26111700 protocol 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28587649 statistical and economic analysis plan 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31072856 qualitative study (added 13/05/2019) 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31608436 baseline characteristics (added 28/10/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32445688/ results (added 22/05/2020) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32389147/ participant characteristics (added 08/10/2020) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32640411/ participant experiences (added 08/10/2020) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31072856/ psychiatrists' perspectives (added 08/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34196269/ (added 05/07/2021)
Investigators
Eligibility 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;
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
Outcomes
Primary Outcomes
Not specified