NCT00688727

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

7.9 years

First QC Date

May 30, 2008

Last Update Submit

January 21, 2009

Conditions

Dissociative Seizures

Keywords

non epileptic seizurescognitive behavioural therapydissociative disordersSeizure disordersrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • seizure frequency

    previous month

Secondary Outcomes (5)

  • seizure freedom

    3 months

  • Work & Social Adjustment scale (Marks, 1986)

    Pre-treatment, end of treatment and six-months follow-up

  • Employment Status

    Pre-treatment, end of treatment and six-months follow-up

  • Health Service Use

    Pre-treatment, end of treatment and six-months follow-up

  • Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)

    Pre-treatment, end of treatment and six-months follow-up

Study Arms (2)

1

EXPERIMENTAL

Cognitive behavioural Therapy

Behavioral: CBT

2

ACTIVE COMPARATOR

Standard Care

Behavioral: Standard Care

Interventions

CBTBEHAVIORAL

CBT, up to 12 sessions.

Also known as: Cognitive Behavioural Therapy
1
Standard CareBEHAVIORAL

Routine review by neuropsychiatrist in outpatient clinic

Also known as: Standard medical care
2

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of dissociative seizures
  • diagnosis confirmed by video EEG telemetry where practicable
  • aged 16 - 70

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maudsley Hospital

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 15209224BACKGROUND

MeSH Terms

Conditions

Psychogenic Nonepileptic SeizuresSeizuresDissociative DisordersEpilepsy

Interventions

Cognitive Behavioral TherapyStandard of Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Laura Goldstein

    Institute of Psychiatry

    STUDY DIRECTOR

  • John Mellers

    Maudsley Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

March 1, 2001

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

GB(1)