Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-04-23 @ 6:11 PM
Study NCT ID:
NCT02506595
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Treatment for Trauma-Related Nightmares in Active Duty Military Personnel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of nightmares reported on the Nightmare Log', 'timeFrame': 'Change from baseline to 2-week posttreatment'}], 'secondaryOutcomes': [{'measure': 'Total score on the Insomnia Severity Index (ISI)', 'timeFrame': 'Change from baseline to 2-week posttreatment'}, {'measure': 'Total score on the Clinician Administered PTSD Scale (CAPS-5)', 'timeFrame': 'Change from baseline to 2-week posttreatment'}, {'measure': 'Total score on the PTSD Checklist -DSM-5 (PCL-5)', 'timeFrame': 'Change from baseline to 2-week posttreatment'}, {'measure': 'Total score on the Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Change from baseline to 2-week posttreatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nightmares']}, 'referencesModule': {'references': [{'pmid': '31957648', 'type': 'DERIVED', 'citation': 'Pruiksma KE, Taylor DJ, Mintz J, Nicholson KL, Rodgers M, Young-McCaughan S, Hall-Clark BN, Fina BA, Dondanville KA, Cobos B, Wardle-Pinkston S, Litz BT, Roache JD, Peterson AL; STRONG STAR Consortium. A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. J Clin Sleep Med. 2020 Jan 15;16(1):29-40. doi: 10.5664/jcsm.8116. Epub 2019 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain preliminary data of the efficacy of Exposure, Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.', 'detailedDescription': 'This will be a pilot randomized controlled trial to compare the effects of Exposure, Relaxation, and Rescripting Therapy for military populations (ERRT-M) among active duty service members. Participants will be randomized to 5 sessions of ERRT-M (n = 20 ) or to a 5-week waitlist control group (WL; n = 20).\n\nParticipants will complete all interviews and self-report measures 1 weeks following treatment or the WL condition and 1 month after completing treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active duty military stationed at Fort Hood as assessed by self-report.\n* Able to speak and read English.\n* History of a traumatic event.\n* Nightmare Disorder\n* Stable on psychotropic and/or hypnotic medications and/or interventions for sleep (e.g., Continuous Positive Air Pressure for sleep apnea) administered by other providers for at least one month assessed by self-report and review of medical record.\n* Willingness to refrain from beginning new behavioral health or medication treatment for issues pertaining to sleep, PTSD, or nightmares during participation in the study.\n* Indication that the SM plans to be in the area for the 5 months following the first assessment\n\nExclusion Criteria:\n\n* Current suicide or homicide risk meriting crisis intervention.\n* Severe brain damage, assessed by the inability to comprehend baseline questionnaires.\n* Pregnancy at baseline.\n* Serious mental health diagnosis such as bipolar disorder or psychosis, assessed with the pre-treatment health interview and review of medical record.\n* Currently taking propranolol.\n* Currently engaged in evidence-based treatment for PTSD (i.e., Prolonged Exposure Therapy or Cognitive Processing Therapy) or Insomnia (i.e., Cognitive Behavioral Therapy for Insomnia).'}, 'identificationModule': {'nctId': 'NCT02506595', 'briefTitle': 'A Trial of Treatment for Trauma-Related Nightmares in Active Duty Military Personnel', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares Compared to Waitlist Control in Active Duty Military Personnel', 'orgStudyIdInfo': {'id': '119-FP-15'}, 'secondaryIdInfos': [{'id': 'HSC20150396H', 'type': 'OTHER', 'domain': 'UTHSCSA IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERRT-M for Nightmares', 'description': 'Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) -', 'interventionNames': ['Behavioral: ERRT-M for Nightmares']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants randomized to the Waitlist control condition will be contacted once weekly for 5 weeks to monitored status and then invited to participant in treatment.'}], 'interventions': [{'name': 'ERRT-M for Nightmares', 'type': 'BEHAVIORAL', 'otherNames': ['Exposure Relaxation & Rescripting'], 'description': 'Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) - Five 60-90 minute sessions administered once weekly. ERRT-M includes psychoeducation, sleep habit modification, relaxation training, written exposure to and rescription of nightmare content and imagery rehearsal of rescripted dream content.', 'armGroupLabels': ['ERRT-M for Nightmares']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'country': 'United States', 'facility': 'Carl R Darnall Army Medical Center', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Sleep Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}