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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
Sponsor:
Collaborator:
Special Trustees for St Thomas' and Guy's Hospitals
Information provided by:
South London and Maudsley NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Dissociative Seizures Behavioral: CBT Behavioral: 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Cognitive behavioural Therapy
Behavioral: CBT
CBT, up to 12 sessions.
Other Name: Cognitive Behavioural Therapy
Active Comparator: 2
Standard Care
Behavioral: Standard Care
Routine review by neuropsychiatrist in outpatient clinic
Other Name: Standard medical care



Primary Outcome Measures :
  1. seizure frequency [ Time Frame: previous month ]

Secondary Outcome Measures :
  1. seizure freedom [ Time Frame: 3 months ]
  2. Work & Social Adjustment scale (Marks, 1986) [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ]
  3. Employment Status [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ]
  4. Health Service Use [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ]
  5. Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
United Kingdom
Maudsley Hospital
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
South London and Maudsley NHS Foundation Trust
Special Trustees for St Thomas' and Guy's Hospitals
Investigators
Study Director: Laura Goldstein Institute of Psychiatry
Principal Investigator: John Mellers Maudsley Hospital

Publications:
Responsible Party: Dr John Mellers, South London and Maudsley NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00688727     History of Changes
Other Study ID Numbers: R000726
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by South London and Maudsley NHS Foundation Trust:
non epileptic seizures
cognitive behavioural therapy
dissociative disorders
Seizure disorders
randomised controlled trial

Additional relevant MeSH terms:
Seizures
Conversion Disorder
Dissociative Disorders
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Somatoform Disorders
Mental Disorders