Cognitive Behavioural Therapy in Dissociative Seizures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by South London and Maudsley NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Special Trustees for St Thomas' and Guy's Hospitals
Information provided by:
South London and Maudsley NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00688727
First received: May 30, 2008
Last updated: January 21, 2009
Last verified: January 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial

Resource links provided by NLM:


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: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 70 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 - 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: May 30, 2008
Last Updated: January 21, 2009
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

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

ClinicalTrials.gov processed this record on October 01, 2014