Cognitive Behavioural Therapy in Dissociative Seizures

January 21, 2009 updated by: South London and Maudsley NHS Foundation Trust

Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
seizure frequency
Time Frame: previous month
previous month

Secondary Outcome Measures

Outcome Measure
Time Frame
seizure freedom
Time Frame: 3 months
3 months
Work & Social Adjustment scale (Marks, 1986)
Time Frame: Pre-treatment, end of treatment and six-months follow-up
Pre-treatment, end of treatment and six-months follow-up
Employment Status
Time Frame: Pre-treatment, end of treatment and six-months follow-up
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
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
Pre-treatment, end of treatment and six-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South London and Maudsley NHS Foundation Trust

Collaborators

Special Trustees for St Thomas' and Guy's Hospitals

Investigators

  • Study Director: Laura Goldstein, Institute of Psychiatry
  • Principal Investigator: John Mellers, Maudsley Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 21, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R000726

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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