Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06695767
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-11-09', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': 'post intervention (14 weeks after baseline)', 'description': 'This is defined as the number enrolled divided by the number of eligible participants screened'}, {'measure': 'Retention rate', 'timeFrame': 'post intervention (14 weeks after baseline)', 'description': 'This is defined as the number completing the study/number enrolled at baseline'}, {'measure': 'Session attendance rate (proportion of sessions attended)', 'timeFrame': 'post intervention (14 weeks after baseline)'}, {'measure': 'Homework completion rate (proportion of homework assignments completed)', 'timeFrame': 'post intervention (14 weeks after baseline)'}, {'measure': 'User satisfaction as assessed by The Participant Satisfaction Survey', 'timeFrame': 'post intervention (14 weeks after baseline)', 'description': 'This is a 16 item questionnaire and the first 10 questions are scored from 1( strongly disagree)to 5(strongly agree) for a maximum score of 50, higher score indicating better outcome'}], 'secondaryOutcomes': [{'measure': 'Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),', 'timeFrame': 'baseline, end of session 12 (12 weeks form baseline)', 'description': 'This is a 9 item questionnaire and each is scored from 0(not at all) to 3(Nearly every day), for a score range of 1-27, higher score indicating worse outcome'}, {'measure': 'Change in quality of Life as assessed by the Quality of Life in Epilepsy Inventory-10 (QOLIE-10)', 'timeFrame': 'baseline, end of session 12(12 weeks form baseline)', 'description': 'This is a 10 item questionnaire , with scores ranging from 0-100, with a higher score indicating better quality of life.'}, {'measure': 'Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)', 'timeFrame': 'baseline, end of session 12(12 weeks form baseline)', 'description': 'This is a 25 item questionnaire, each rated on a 5-point scale from 0(not true at all) to 4(true nearly all the time), with higher scores reflecting greater resilience.'}, {'measure': 'Change in efficacy in the self management of epilepsy as assessed by the Epilepsy Self-Efficacy Scale (ESES)', 'timeFrame': 'baseline, end of session 12(12 weeks form baseline)', 'description': 'This is a 33 item questionnaire , rated on a 11-point Likert scale, ranging from 0(I cannot do it at all) to 10(sure I can do) for a maximum score of 330, higher score indicating better outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['veterans'], 'conditions': ['Major Depressive Disorder', 'Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking veterans\n* has home internet access\n* has access to and familiarity in using a computer or tablet at least weekly\n* Asymptomatic patients with chronic conditions\n* has access to a mobile device with Short Message Service (SMS) text and picture capability\n* has an active clinical diagnosis of major depressive disorder based on the International Classification of Diseases, 10th version (ICD-10)\n* has an ICD-10 diagnosis of epilepsy with at least one seizure documented within the last five years\n\nExclusion Criteria:\n\n* pregnancy\n* Veterans that have current suicidal ideation\n* have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.'}, 'identificationModule': {'nctId': 'NCT06695767', 'briefTitle': 'Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'H-53437'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurobehavioral therapy', 'interventionNames': ['Behavioral: Neurobehavioral therapy']}], 'interventions': [{'name': 'Neurobehavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will receive an introduction session and 12 1-hour long online sessions once per week for a total of 12 weeks that are guided by the investigator who is trained in NBT.Participants will engage in tools to aid in assuming control over their seizures; contextualize their environment; identify moods, situations, and thoughts; train healthy communication and support seeking; understand central nervous system medications and seizures; conduct a functional behavioral analysis; learn relaxation techniques; examine external stressors and internal triggers; and prepare for life after the intervention. Participants will be asked to complete weekly homework, thought records, seizure logs that are found in their workbooks and to engage in journal entries.', 'armGroupLabels': ['Neurobehavioral therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Fadipe, MSN, APRN, FNP-C', 'role': 'CONTACT', 'email': 'Melissa.F.Fadipe@uth.tmc.edu', 'phone': '(713) 825-7237'}, {'name': 'Jennifer Beauchamp', 'role': 'CONTACT', 'email': 'Jennifer.E.Beauchamp@uth.tmc.edu', 'phone': '(713) 500-2114'}], 'facility': 'Michael E. DeBakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Fadipe, MSN, APRN, FNP-C', 'role': 'CONTACT', 'email': 'Melissa.F.Fadipe@uth.tmc.edu', 'phone': '(713) 825-7237'}, {'name': 'Jennifer Beauchamp', 'role': 'CONTACT', 'email': 'Jennifer.E.Beauchamp@uth.tmc.edu', 'phone': '(713) 500-2114'}], 'facility': 'The University of Texas health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Melissa Fadipe, MSN, APRN, FNP-C', 'role': 'CONTACT', 'email': 'Melissa.F.Fadipe@uth.tmc.edu', 'phone': '(713) 825-7237'}, {'name': 'Jennifer Beauchamp', 'role': 'CONTACT', 'email': 'Jennifer.E.Beauchamp@uth.tmc.edu', 'phone': '(713) 500-2114'}], 'overallOfficials': [{'name': 'Melissa Fadipe, MSN, APRN, FNP-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Melissa Fadipe', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}