Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00688727
Status:
UNKNOWN
Last Update Posted:
2009-01-22
First Post:
2008-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Behavioural Therapy in Dissociative Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000091323', 'term': 'Psychogenic Nonepileptic Seizures'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004213', 'term': 'Dissociative Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-21', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seizure frequency', 'timeFrame': 'previous month'}], 'secondaryOutcomes': [{'measure': 'seizure freedom', 'timeFrame': '3 months'}, {'measure': 'Work & Social Adjustment scale (Marks, 1986)', 'timeFrame': 'Pre-treatment, end of treatment and six-months follow-up'}, {'measure': 'Employment Status', 'timeFrame': 'Pre-treatment, end of treatment and six-months follow-up'}, {'measure': 'Health Service Use', 'timeFrame': 'Pre-treatment, end of treatment and six-months follow-up'}, {'measure': 'Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)', 'timeFrame': 'Pre-treatment, end of treatment and six-months follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non epileptic seizures', 'cognitive behavioural therapy', 'dissociative disorders', 'Seizure disorders', 'randomised controlled trial'], 'conditions': ['Dissociative Seizures']}, 'referencesModule': {'references': [{'pmid': '15209224', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOur hypothesis is that CBT will be superior to standard outpatient care for patients with dissociative seizures as determined by the above measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of dissociative seizures\n* diagnosis confirmed by video EEG telemetry where practicable\n* aged 16 - 70\n\nExclusion Criteria:\n\n* co existent diagnosis (past or present) of epilepsy\n* seizure frequency of less than 2 seizures per month\n* current alcohol or drug abuse\n* benzodiazepine use exceeding the equivalent of 10mg diazepam per day.'}, 'identificationModule': {'nctId': 'NCT00688727', 'briefTitle': 'Cognitive Behavioural Therapy in Dissociative Seizures', 'organization': {'class': 'OTHER', 'fullName': 'South London and Maudsley NHS Foundation Trust'}, 'officialTitle': 'Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'R000726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cognitive behavioural Therapy', 'interventionNames': ['Behavioral: CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Standard Care', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'CBT', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioural Therapy'], 'description': 'CBT, up to 12 sessions.', 'armGroupLabels': ['1']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'otherNames': ['Standard medical care'], 'description': 'Routine review by neuropsychiatrist in outpatient clinic', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 8AF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Maudsley Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Laura Goldstein', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Psychiatry'}, {'name': 'John Mellers', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maudsley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South London and Maudsley NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': "Special Trustees for St Thomas' and Guy's Hospitals", 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr John Mellers', 'oldOrganization': 'South London and Maudsley NHS Foundation Trust'}}}}