Cognitive Behavioural Therapy in Dissociative Seizures

Study Overview
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Brief Summary
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The purpose of this study is to determine whether adults with disoociative (psychogenic non-epileptic) seizures receiving cognitive behavioural therapy (CBT) show a greater reduction in seizures and health service use and greater improvement in employment status and overall psychosocial functioning than patients who receive standard care.

Detailed Description
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Preliminary results from a pilot study demonstrated that cognitive behavioural therapy (CBT) is associated with a significant benefit for patients with dissociative seizures. The current study aims to extend these findings by conducting a randomised controlled trial comparing CBT with standard outpatient medical care. Standard outpatient care has been chosen as the comparison treatment as it most closely resembles what is currently offered to this group of patients by the National Health Service. The primary outcome measure will be seizure frequency. Secondary outcome measures will be work and social adjustment and health service use. Our hypothesis is that CBT will be superior to standard outpatient care for patients with dissociative seizures as determined by the above measures.

Official Title
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Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial

Conditions
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Dissociative Seizures

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of dissociative seizures diagnosis confirmed by video EEG telemetry where practicable aged 16 - 70 Exclusion Criteria: co existent diagnosis (past or present) of epilepsy seizure frequency of less than 2 seizures per month current alcohol or drug abuse benzodiazepine use exceeding the equivalent of 10mg diazepam per day.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive behavioural Therapy | Behavioral: CBT<br>* CBT, up to 12 sessions.<br>* Other names: Cognitive Behavioural Therapy;|
| Active Comparator: 2<br>Standard Care | Behavioral: Standard Care<br>* Routine review by neuropsychiatrist in outpatient clinic<br>* Other names: Standard medical care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure frequency |  | previous month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure freedom |  | 3 months | 
| Work & Social Adjustment scale (Marks, 1986) |  | Pre-treatment, end of treatment and six-months follow-up | 
| Employment Status |  | Pre-treatment, end of treatment and six-months follow-up | 
| Health Service Use |  | Pre-treatment, end of treatment and six-months follow-up | 
| Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) |  | Pre-treatment, end of treatment and six-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non epileptic seizures, cognitive behavioural therapy, dissociative disorders, Seizure disorders, randomised controlled trial