Cognitive Behavioural Therapy in Dissociative Seizures

Dissociative Seizures Clinical Trial

Official title:

Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00688727
• Other study ID #: R000726
• Status: Active, not recruiting
• Phase: N/A
• First received: May 30, 2008
• Last updated: January 21, 2009
• Start date: March 2001
• Est. completion date: February 2009

Study information

• Verified date: January 2009
• Source: South London and Maudsley NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Dissociative Seizures
• Seizures

Intervention

Behavioral:
• CBT
CBT, up to 12 sessions.
• Standard Care
Routine review by neuropsychiatrist in outpatient clinic

Locations

Country	Name	City	State
United Kingdom	Maudsley Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
South London and Maudsley NHS Foundation Trust	Special Trustees for St Thomas' and Guy's Hospitals

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure frequency		previous month	No
Secondary	seizure freedom		3 months	No
Secondary	Work & Social Adjustment scale (Marks, 1986)		Pre-treatment, end of treatment and six-months follow-up	No
Secondary	Employment Status		Pre-treatment, end of treatment and six-months follow-up	No
Secondary	Health Service Use		Pre-treatment, end of treatment and six-months follow-up	No
Secondary	Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)		Pre-treatment, end of treatment and six-months follow-up	No