Dissociative SeizuresNCT00688727
Cognitive Behavioural Therapy in Dissociative Seizures
A study testing CBT in people with Dissociative Seizures, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Dissociative Seizures
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2001to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of dissociative seizures
- diagnosis confirmed by video EEG telemetry where practicable
- aged 16 - 70
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dissociative Seizures
- Being tested
- CBT, Standard Care
- Keywords
- non epileptic seizures, cognitive behavioural therapy, dissociative disorders, Seizure disorders, randomised controlled trial
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Seizures, Dissociative Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Also called Cognitive Behavioural Therapy
CBT, up to 12 sessions.
Standard CareBehavioural
Also called Standard medical care
Routine review by neuropsychiatrist in outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive behavioural Therapy Receives: Behavioral: CBT |
| 2 | Active comparator | Standard Care Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure frequency
Measured: previous month
Secondary outcomes (5)
seizure freedom
Measured: 3 months
Work & Social Adjustment scale (Marks, 1986)
Measured: Pre-treatment, end of treatment and six-months follow-up
Employment Status
Measured: Pre-treatment, end of treatment and six-months follow-up
Health Service Use
Measured: Pre-treatment, end of treatment and six-months follow-up
Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
Measured: Pre-treatment, end of treatment and six-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMar 2001
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dissociative SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Special Trustees for St Thomas' and Guy's Hospitals
- Investigators
- Laura Goldstein, Study director, Institute of PsychiatryJohn Mellers, Principal investigator, Maudsley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688727
- Sponsor's protocol ID
- R000726
- Status last verified
- Jan 2009
- First submitted
- 30 May 2008
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/00146965-200403000-00005.
PubMed 15209224
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00688727
- Acronym / sponsor ID
- R000726
- Conditions
- Dissociative Seizures
- Keywords
- non epileptic seizures, cognitive behavioural therapy, dissociative disorders, Seizure disorders, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Special Trustees for St Thomas' and Guy's Hospitals
- Study start
- Mar 2001
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: CBTCognitive behavioural Therapy |
| 2 | Active comparator | Behavioral: Standard CareStandard Care |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of dissociative seizures
- diagnosis confirmed by video EEG telemetry where practicable
- aged 16 - 70
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTAlso: Cognitive Behavioural TherapyCBT, up to 12 sessions. | Behavioural | 1 |
| Standard CareAlso: Standard medical careRoutine review by neuropsychiatrist in outpatient clinic | Behavioural | 2 |
Primary outcome
seizure frequency
Time frame: previous month
5 secondary outcomes
seizure freedom
Time frame: 3 months
Work & Social Adjustment scale (Marks, 1986)
Time frame: Pre-treatment, end of treatment and six-months follow-up
Employment Status
Time frame: 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
Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
Time frame: Pre-treatment, end of treatment and six-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Background: PubMed 15209224Goldstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Goldstein study director
Institute of Psychiatry
John Mellers principal investigator
Maudsley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Dissociative Seizures, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure frequency (time frame: previous month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00688727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009; AzTrials last refreshed its copy on 31 Oct 2026.