Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 10:19 PM
Study NCT ID:
NCT07344766
Status:
COMPLETED
Last Update Posted:
2026-01-16
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Psychogenic Nonepileptic Seizures and Post-traumatic Stress Disorder Using Prolonged Exposure Therapy (PE) or Psychoeducation for PNES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000091323', 'term': 'Psychogenic Nonepileptic Seizures'}, {'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D012640', 'term': 'Seizures'}], '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': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nonepileptic seizure frequency', 'timeFrame': 'From enrollment until session 12 and at 3, 6 and 12month follow up', 'description': 'frequency of nonepileptic seizures (PNES) per month'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'From enrollment to session 12 and at 3, 6 and 12 months follow up', 'description': 'Self-report inventory of depressive symptoms 0-13: minimal depression, 14-19: mild, 20-28: moderate, 29-63: severe'}, {'measure': 'Posttraumatic Stress Disorder Checklist (PCL) for DSM 5', 'timeFrame': 'From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up', 'description': 'Post traumatic stress symptom checklist scores range from 0-80, higher score means worse outcome'}, {'measure': 'Posttraumatic Diagnostic Scale', 'timeFrame': 'From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up', 'description': 'post traumatic diagnostic scale 0: No symptoms, 1-10: Mild symptoms, 11-20: Moderate symptoms, 21-35: Moderate to severe symptoms, \\>36: Severe symptoms.'}, {'measure': 'Clinician Administered PTSD Scale for DSM 5 (CAPS)', 'timeFrame': 'From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up', 'description': 'Clinician-Administered PTSD Scale for DSM 5. Severity rating: 0: absent, 1: mild, 2: moderate, 3: severe, 4: extreme'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychotherapy', 'functional dissociative seizures', 'nonepileptic seizures', 'psychogenic nonepileptic seizures'], 'conditions': ['Psychogenic Nonepileptic Seizures (PNESs)', 'Post Traumatic Stress Disorder PTSD']}, 'referencesModule': {'references': [{'pmid': '28038392', 'type': 'BACKGROUND', 'citation': 'Myers L, Vaidya-Mathur U, Lancman M. Prolonged exposure therapy for the treatment of patients diagnosed with psychogenic non-epileptic seizures (PNES) and post-traumatic stress disorder (PTSD). Epilepsy Behav. 2017 Jan;66:86-92. doi: 10.1016/j.yebeh.2016.10.019. Epub 2016 Dec 27.'}, {'pmid': '15256198', 'type': 'BACKGROUND', 'citation': 'Zaroff CM, Myers L, Barr WB, Luciano D, Devinsky O. Group psychoeducation as treatment for psychological nonepileptic seizures. Epilepsy Behav. 2004 Aug;5(4):587-92. doi: 10.1016/j.yebeh.2004.03.005.'}]}, 'descriptionModule': {'briefSummary': "An outpatient randomized controlled clinical trial conducted at the Northeast Regional Epilepsy Group's PNES Program, involving mental health clinicians certified in PE and trained in administering PsychoEd.", 'detailedDescription': 'A randomized parallel group trial was utilized to compare two therapeutic interventions for PNES, PE or PsychoEd, both delivered remotely via teletherapy. Each psychotherapeutic modality provided 12, 90-minute sessions. Seizure frequency was the primary outcome measure. Secondary outcome measures were depression (Beck Depression Inventory) and post-traumatic stress symptomatology (Post-Traumatic Disorder Diagnostic Scale and PTSD Checklist). Data was collected prospectively, including baseline measures before initiating treatment, upon treatment completion, and at follow-up intervals of 3, 6, and 12-months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEnglish-speaking adults (18 years and older) Confirmed diagnosis of PNES through video-EEG monitoring Confirmed diagnosis of current PTSD At least one psychogenic non-epileptic seizure in the month prior to beginning treatment.\n\nExclusion Criteria:\n\nConcurrent mixed epilepsy and PNES or video EEG findings that cannot clearly distinguish epilepsy and PNES Active suicidality Active psychotic symptoms Active substance or alcohol use or dependence that could interfere with participation in therapy Application for disability\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07344766', 'acronym': 'PNES', 'briefTitle': 'Treatment for Psychogenic Nonepileptic Seizures and Post-traumatic Stress Disorder Using Prolonged Exposure Therapy (PE) or Psychoeducation for PNES', 'organization': {'class': 'OTHER', 'fullName': 'Northeast Regional Epilepsy Group'}, 'officialTitle': 'Pilot Prolonged Exposure Teletherapy Treatment Trial for Psychogenic Nonepileptic Seizures (PNES) and Post-traumatic Stress Disorder (PTSD): A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'WCGIRB 1280734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prolonged exposure', 'interventionNames': ['Behavioral: imaginal and in vivo exposure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducational Intervention for PNES', 'description': 'This psychoeducational treatment was based on a similar intervention reported in 2004', 'interventionNames': ['Behavioral: psychoeducation for psychogenic nonepileptic seizures']}], 'interventions': [{'name': 'imaginal and in vivo exposure', 'type': 'BEHAVIORAL', 'description': 'Prolonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders', 'armGroupLabels': ['Prolonged exposure']}, {'name': 'psychoeducation for psychogenic nonepileptic seizures', 'type': 'BEHAVIORAL', 'otherNames': ['PsychoEd for PNES'], 'description': 'A combination of psychoeducation about PNES and skills for emotional regulation and relaxation.', 'armGroupLabels': ['Psychoeducational Intervention for PNES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northeast Regional Epilepsy Group', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Lorna Myers, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NEREG'}]}, 'ipdSharingStatementModule': {'url': 'https://support.dataverse.harvard.edu/', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'upon completion of final data analysis until indefinitely.', 'ipdSharing': 'YES', 'description': 'Protocol and data collected over the duration of the study.', 'accessCriteria': 'Qualified researchers will have access to de-identified IPD, protocol, informed consent) via online data repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeast Regional Epilepsy Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, PNES Program', 'investigatorFullName': 'Dr. Lorna Myers', 'investigatorAffiliation': 'Northeast Regional Epilepsy Group'}}}}