Cognitive Behavioural Therapy in Dissociative Seizures - Full Text View

Sponsors and Collaborators:	South London and Maudsley NHS Foundation Trust Special Trustees for St Thomas' and Guy's Hospitals
Information provided by:	South London and Maudsley NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00688727

Purpose

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
Dissociative Seizures	Behavioral: CBT Behavioral: Standard Care

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

U.S. FDA Resources

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

Further study details as provided by South London and Maudsley NHS Foundation Trust:

Primary Outcome Measures:

seizure frequency [ Time Frame: previous month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

seizure freedom [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Work & Social Adjustment scale (Marks, 1986) [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ] [ Designated as safety issue: No ]
Employment Status [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ] [ Designated as safety issue: No ]
Health Service Use [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) [ Time Frame: Pre-treatment, end of treatment and six-months follow-up ] [ Designated as safety issue: No ]

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
1: Experimental Cognitive behavioural Therapy	Behavioral: CBT CBT, up to 12 sessions.
2: Active Comparator Standard Care	Behavioral: Standard Care Routine review by neuropsychiatrist in outpatient clinic

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.

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinical diagnosis of dissociative seizures
diagnosis confirmed by video EEG telemetry where practicable
aged 16 - 65

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688727

Contacts

Contact: John DC Mellers, MBBS

0203

mellers@winstreet.u-net.com

Locations

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

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

More Information

Publications:

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.

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

Keywords provided by South London and Maudsley NHS Foundation Trust:

non epileptic seizures
cognitive behavioural therapy
dissociative disorders
Seizure disorders
randomised controlled trial

Study placed in the following topic categories:

Signs and Symptoms
Conversion disorder
Mental Disorders
Epilepsy
Seizures
Neurologic Manifestations

Central Nervous System Diseases
Dissociative Disorders
Somatoform Disorders
Brain Diseases
Conversion Disorder
Hysteria

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009