Cognitive Behavioural Therapy in Dissociative Seizures
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|ClinicalTrials.gov Identifier: NCT00688727|
Recruitment Status : Unknown
Verified January 2009 by South London and Maudsley NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : June 3, 2008
Last Update Posted : January 22, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dissociative Seizures||Behavioral: CBT Behavioral: Standard Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial|
|Study Start Date :||March 2001|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||February 2009|
Cognitive behavioural Therapy
CBT, up to 12 sessions.
Other Name: Cognitive Behavioural Therapy
Active Comparator: 2
Behavioral: Standard Care
Routine review by neuropsychiatrist in outpatient clinic
Other Name: Standard medical care
- seizure frequency [ Time Frame: previous month ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688727
|London, United Kingdom, SE5 8AF|
|Study Director:||Laura Goldstein||Institute of Psychiatry|
|Principal Investigator:||John Mellers||Maudsley Hospital|