Cognitive behavioural therapy vs standardised medical care for dissociative non-epileptic seizures

Not Applicable

Completed

• Conditions: Dissociative seizures (also referred to as psychogenic nonepileptic seizures); Nervous System Diseases

• Registration Number: ISRCTN05681227
• Lead Sponsor: King's College London

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Study Completion: 2020-03-31
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 368

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br><br> Added 31/03/2020:<br> Frequency will also be measured at baseline and 6 months post-randomisation but the outcome will be assessed at 12 months post-randomisation.<br>