Cognitive Behavioural Therapy in Dissociative Seizures
Primary Purpose
Dissociative Seizures
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CBT
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Dissociative Seizures focused on measuring non epileptic seizures, cognitive behavioural therapy, dissociative disorders, Seizure disorders, randomised controlled trial
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.
Sites / Locations
- Maudsley Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Cognitive behavioural Therapy
Standard Care
Outcomes
Primary Outcome Measures
seizure frequency
Secondary Outcome Measures
seizure freedom
Work & Social Adjustment scale (Marks, 1986)
Employment Status
Health Service Use
Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
Full Information
NCT ID
NCT00688727
First Posted
May 30, 2008
Last Updated
January 21, 2009
Sponsor
South London and Maudsley NHS Foundation Trust
Collaborators
Special Trustees for St Thomas' and Guy's Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00688727
Brief Title
Cognitive Behavioural Therapy in Dissociative Seizures
Official Title
Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
South London and Maudsley NHS Foundation Trust
Collaborators
Special Trustees for St Thomas' and Guy's Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dissociative Seizures
Keywords
non epileptic seizures, cognitive behavioural therapy, dissociative disorders, Seizure disorders, randomised controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive behavioural Therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard Care
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
CBT, up to 12 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Standard medical care
Intervention Description
Routine review by neuropsychiatrist in outpatient clinic
Primary Outcome Measure Information:
Title
seizure frequency
Time Frame
previous month
Secondary Outcome Measure Information:
Title
seizure freedom
Time Frame
3 months
Title
Work & Social Adjustment scale (Marks, 1986)
Time Frame
Pre-treatment, end of treatment and six-months follow-up
Title
Employment Status
Time Frame
Pre-treatment, end of treatment and six-months follow-up
Title
Health Service Use
Time Frame
Pre-treatment, end of treatment and six-months follow-up
Title
Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
Time Frame
Pre-treatment, end of treatment and six-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Goldstein
Organizational Affiliation
Institute of Psychiatry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Mellers
Organizational Affiliation
Maudsley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maudsley Hospital
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15209224
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.
Results Reference
background
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Cognitive Behavioural Therapy in Dissociative Seizures
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