Cognitive Behavioural Therapy in Dissociative Seizures

NCT ID: NCT00688727

Last Updated: 2009-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Dissociative Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cognitive behavioural Therapy

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

CBT, up to 12 sessions.

2

Standard Care

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Routine review by neuropsychiatrist in outpatient clinic

Interventions

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CBT

CBT, up to 12 sessions.

Intervention Type BEHAVIORAL

Standard Care

Routine review by neuropsychiatrist in outpatient clinic

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioural Therapy Standard medical care

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Special Trustees for St Thomas' and Guy's Hospitals

UNKNOWN

Sponsor Role collaborator

South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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South London and Maudsley NHS Foundation Trust

Principal Investigators

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Laura Goldstein

Role: STUDY_DIRECTOR

Institute of Psychiatry

John Mellers

Role: PRINCIPAL_INVESTIGATOR

Maudsley Hospital

Locations

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Maudsley Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 15209224 (View on PubMed)

Other Identifiers

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R000726

Identifier Type: -

Identifier Source: org_study_id

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