Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT03831412
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2018-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2018-10-27', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia Severity Index', 'timeFrame': 'From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion', 'description': 'Change in frequency of insomnia symptoms'}, {'measure': 'Change in Insomnia Severity Index', 'timeFrame': 'From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion', 'description': 'Change in severity of insomnia symptoms'}, {'measure': 'Change in Sleep log', 'timeFrame': 'From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion', 'description': 'Change in frequency of nightmares'}, {'measure': 'Change in Sleep log', 'timeFrame': 'From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion', 'description': 'Change in severity of nightmares'}, {'measure': 'Change in Beck Suicide Scale', 'timeFrame': 'From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion', 'description': 'Change in severity of suicidal ideation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Nightmare', 'Trauma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://nightmaretreatment.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* experiences at least one nightmare per week for the past month\n* having previously experienced a traumatic event\n* difficulty falling or staying asleep\n* suicidal ideation\n* actively under the care of another health care provider\n\nExclusion Criteria:\n\n* untreated obstructive sleep apnea\n* acute or apparent psychosis\n* untreated or unstable bipolar disorder\n* past history of seizure disorder or neurological disorder\n* intellectual disability\n* current substance dependence or in past 6 months'}, 'identificationModule': {'nctId': 'NCT03831412', 'briefTitle': 'Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Tulsa'}, 'officialTitle': 'CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation', 'orgStudyIdInfo': {'id': 'TU1802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CBT-I', 'description': '5 sessions of treating insomnia', 'interventionNames': ['Behavioral: CBT-I']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ERRT', 'description': '5 sessions of treating post-trauma nightmares', 'interventionNames': ['Behavioral: ERRT']}], 'interventions': [{'name': 'CBT-I', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Therapy for Insomnia'], 'description': 'Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.', 'armGroupLabels': ['CBT-I']}, {'name': 'ERRT', 'type': 'BEHAVIORAL', 'otherNames': ['Exposure, Relaxation, Rescripting Therapy'], 'description': 'Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.', 'armGroupLabels': ['ERRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lorton Hall', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tulsa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joanne Davis', 'investigatorAffiliation': 'University of Tulsa'}}}}