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Sponsors and Collaborators: |
South London and Maudsley NHS Foundation Trust Special Trustees for St Thomas' and Guy's Hospitals |
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Information provided by: | South London and Maudsley NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00688727 |
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.
Condition | Intervention |
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Dissociative Seizures |
Behavioral: CBT Behavioral: Standard Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial |
Estimated Enrollment: | 70 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cognitive behavioural Therapy
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Behavioral: CBT
CBT, up to 12 sessions.
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2: Active Comparator
Standard Care
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Behavioral: Standard Care
Routine review by neuropsychiatrist in outpatient clinic
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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.
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John DC Mellers, MBBS | 0203 | mellers@winstreet.u-net.com |
United Kingdom | |
Maudsley Hospital | Recruiting |
London, United Kingdom, SE5 8AF | |
Contact: John DC Mellers, MBBS +44 (0) 203228 2330 John.Mellers@slam.nhs.uk | |
Contact: Laura Goldstein, PhD, M Phil l.goldstein@iop.kcl.ac.uk | |
Sub-Investigator: Laura Goldstein, Ph D, M Phil |
Study Director: | Laura Goldstein | Institute of Psychiatry |
Principal Investigator: | John Mellers | Maudsley Hospital |
Responsible Party: | South London and Maudsley NHS Foundation Trust ( Dr John Mellers ) |
Study ID Numbers: | R000726 |
Study First Received: | May 30, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00688727 |
Health Authority: | United Kingdom: Research Ethics Committee |
non epileptic seizures cognitive behavioural therapy dissociative disorders Seizure disorders randomised controlled trial |
Signs and Symptoms Conversion disorder Mental Disorders Epilepsy Seizures Neurologic Manifestations |
Central Nervous System Diseases Dissociative Disorders Somatoform Disorders Brain Diseases Conversion Disorder Hysteria |
Nervous System Diseases |