Cognitive Behavioural Therapy in Dissociative Seizures

• Sponsor: South London and Maudsley NHS Foundation Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00688727
• Collaborator: Special Trustees for St Thomas' and Guy's Hospitals (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 95.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dissociative Seizures	Behavioral: CBT; Behavioral: Standard Care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial
• Study Start Date: Mar 1, 2001
• Anticipated Primary Completion Date: Feb 1, 2009
• Anticipated Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. seizure frequency [previous month]

Secondary Outcome Measures

1. seizure freedom [3 months]

2. Work & Social Adjustment scale (Marks, 1986) [Pre-treatment, end of treatment and six-months follow-up]

3. Employment Status [Pre-treatment, end of treatment and six-months follow-up]

4. Health Service Use [Pre-treatment, end of treatment and six-months follow-up]

5. Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) [Pre-treatment, end of treatment and six-months follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00688727
• Other Study ID Numbers: R000726
• First Posted: Jun 3, 2008
• Last Update Posted: Jan 22, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: non epileptic seizures; cognitive behavioural therapy; dissociative disorders; Seizure disorders; randomised controlled trial
• Additional relevant MeSH terms: Seizures; Conversion Disorder; Dissociative Disorders

Study Results

No Results Posted as of Jan 22, 2009