This trial is active, not recruiting.

Condition dissociative seizures
Treatments cbt, standard care
Sponsor South London and Maudsley NHS Foundation Trust
Collaborator Special Trustees for St Thomas' and Guy's Hospitals
Start date March 2001
End date February 2009
Trial size 70 participants
Trial identifier NCT00688727, R000726


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Cognitive behavioural Therapy
cbt Cognitive Behavioural Therapy
CBT, up to 12 sessions.
(Active Comparator)
Standard Care
standard care Standard medical care
Routine review by neuropsychiatrist in outpatient clinic

Primary Outcomes

seizure frequency
time frame: previous month

Secondary Outcomes

seizure freedom
time frame: 3 months
Work & Social Adjustment scale (Marks, 1986)
time frame: Pre-treatment, end of treatment and six-months follow-up
Employment Status
time frame: Pre-treatment, end of treatment and six-months follow-up
Health Service Use
time frame: Pre-treatment, end of treatment and six-months follow-up
Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
time frame: Pre-treatment, end of treatment and six-months follow-up

Eligibility Criteria

Male or female participants from 16 years up to 70 years old.

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.

Additional Information

Official title Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial
Principal investigator John Mellers
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by South London and Maudsley NHS Foundation Trust.