Clinical trial NCT00688727: Cognitive Behavioural Therapy in Dissociative Seizures
Official title: Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dissociative Seizures
Keywords: non epileptic seizures
cognitive behavioural therapy
dissociative disorders
Seizure disorders
randomised controlled trial
Lead sponsor: South London and Maudsley NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Special Trustees for St Thomas' and Guy's Hospitals
First posted: 2008-06-03
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: seizure frequency
timeFrame: previous month
Secondary outcomes:
measure: seizure freedom
timeFrame: 3 months
measure: Work & Social Adjustment scale (Marks, 1986)
timeFrame: Pre-treatment, end of treatment and six-months follow-up
measure: Employment Status
timeFrame: Pre-treatment, end of treatment and six-months follow-up
measure: Health Service Use
timeFrame: Pre-treatment, end of treatment and six-months follow-up
measure: Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
timeFrame: Pre-treatment, end of treatment and six-months follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Maudsley Hospital
Study officials:
affiliation: Institute of Psychiatry
name: Laura Goldstein
role: STUDY_DIRECTOR
affiliation: Maudsley Hospital
name: John Mellers
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldstein LH, Deale AC, Mitchell-O'Malley SJ, Toone BK, Mellers JD. An evaluation of cognitive behavioral therapy as a treatment for dissociative seizures: a pilot study. Cogn Behav Neurol. 2004 Mar;17(1):41-9. doi: 10.1097/00146965-200403000-00005.